[Federal Register Volume 75, Number 58 (Friday, March 26, 2010)]
[Proposed Rules]
[Pages 14510-14538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6662]
[[Page 14510]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 807
[Docket No. FDA-2009-N-0114]
RIN 0910-AF88
Implementation of Device Registration and Listing Requirements
Enacted in the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, the Medical Device User Fee and Modernization Act
of 2002, and Title II of the Food and Drug Administration Amendments
Act of 2007
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration is proposing to amend its
regulations governing medical device establishment registration and
device listing. The proposed revisions would modify FDA's current
regulations at part 807 (21 CFR part 807) to reflect recent statutory
amendments to the device registration and listing provisions of the
Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug
Administration Amendments Act of 2007 (FDAAA), which was enacted on
September 27, 2007, amended section 510 of the FD&C Act by requiring
domestic and foreign device establishments to begin submitting their
registration and device listing information to FDA by electronic means
rather than on paper forms, and also specified the timeframes when
establishments are required to submit such information. In accordance
with FDAAA, the agency launched FDA's Unified Registration and Listing
System (FURLS), and Internet-based registration and listing system.
FDAAA requires electronic submission of device registration and listing
information unless FDA grants a waiver request.
In addition, this proposal would facilitate FDA's collection of
additional registration information from foreign establishments as
required by the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (Bioterrorism Act). It also would update
certain provisions in part 807 to improve the quality of registration
and listing information available to FDA. FDA relies on having complete
and accurate registration and listing information in order to
accomplish a number of important public health objectives.
DATES: Submit written or electronic comments on the proposed rule by
June 24, 2010. Submit comments on information collection issues under
the Paperwork Reduction Act of 1995 by April 26, 2010, (see the
``Paperwork Reduction Act of 1995'' section of this document). See
sections IX and X of this document for the proposed effective and
proposed compliance dates of a final rule based on this document.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0114 and RIN number 0910-AF88, by any of the following methods,
except that comments on information collection issues under the
Paperwork Reduction Act of 1995 must be submitted to the Office of
Regulatory Affairs, Office of Management and Budget (OMB) at FAX: 202-
395-7285, or e-mail comments to [email protected]. Please
mark your comments to the attention of the FDA desk officer and
reference this rule.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number found in brackets in the heading of this document into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Theresa McDonald, Center for Devices
and Radiological Health (HFZ-307), Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5823.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Summary of Current Registration and Listing Requirements
A. Summary of Section 510 of the FD&C Act (21 U.S.C. 360)
B. Summary of Current Registration and Listing Regulations
III. Highlights of the Proposed Changes to the Current Registration and
Listing Requirements
IV. Description of the Proposed Rule
A. General
B. Registration
C. Listing
D. Electronic Format
E. Miscellaneous
F. Conforming Actions
V. Legal Authority
VI. Analysis of Economic Impacts
A. The Need for Regulation
B. Background
C. The Proposed Regulation
D. Estimated Impacts
E. Impact on Small Entities
VII. Paperwork Reduction Act of 1995
A. Statutory Compliance
B. Transition Process From Paper to Electronic Submission
VIII. Environmental Impact
IX. Proposed Effective Date
X. Proposed Compliance Dates
XI. Federalism
XII. Request for Comments
XIII. References
I. Background
We originally published establishment registration regulations for
medical devices in the Federal Register of September 3, 1976 (41 FR
37458) (proposed rule) and August 23, 1977 (42 FR 42520) (final rule),
and device listing regulations in the Federal Register of September 30,
1977 (42 FR 52808) (proposed rule), and August 25, 1978 (43 FR 37990)
(final rule).
These regulations called for establishment registration and device
listing information to be submitted to the Center for Devices and
Radiological Health (CDRH) on several paper forms: FDA 2891,
Registration of Device Establishment; FDA 2891a, Annual Registration of
Device Establishment; and FDA 2892, Device Listing. Once these forms
were completed and submitted to FDA, FDA then forwarded them to a data
entry contractor who entered the information into FDA's device
registration and listing database.
In June 2002, section 321 of the Bioterrorism Act amended section
510(i) of the FD&C Act to require those foreign
[[Page 14511]]
establishments who are required to register with FDA to do so by
electronic means, and to include additional information identifying
certain parties involved in the importation of the foreign
establishment's devices into the United States as part of their
registration. Subsequently, in October 2002, section 207 of MDUFMA
further amended section 510 of the FD&C Act by extending the
requirement for electronic submission of registration information to
include domestic firms as well as foreign firms. However, when adding
these new electronic submission requirements, which appear in section
510(p) of the FD&C Act, Congress chose to delay their implementation so
that FDA would have an opportunity to first put systems in place to
accommodate the electronic receipt of registration information. This
was accomplished by including a requirement in section 510(p) of the
FD&C Act for the Secretary of the Department of Health and Human
Services (the Secretary) to make a finding that the electronic receipt
of registration information was feasible before implementing electronic
registration.
As reflected in FDAAA, the most recent legislation establishing
changes to FDA's device registration and listing program, FDA has now
developed a system that makes the electronic receipt of device
registration and listing information feasible. FDAAA amended section
510(p) of the FD&C Act by eliminating the need for a feasibility
finding and requiring both establishment registration and device
listing information to be submitted using electronic means unless FDA
grants a waiver request. In accordance with FDAAA, FDA's Unified
Registration and Listing System (FURLS), which is a new Internet-based
system, became operational on October 1, 2007. FDA believes this
electronic system will ultimately make the process of submitting
registration and listing information more efficient for industry and
will provide faster access to this information for both FDA and
industry.
In addition, the new electronic system will allow FDA to more
effectively gather information concerning marketed devices. We rely on
having complete and accurate registration and listing information to
accomplish a number of important statutory and regulatory objectives.
For example, we use registration and listing information to:
Identify establishments producing marketed medical
devices;
Identify establishments producing a specific device when
that device is in short supply or is needed for a national emergency.
This information helps us facilitate prompt shipment of devices to the
places where they are needed most. For example, during a bioterrorism
incident, we could use device listing information to identify
establishments that could be helpful in preventing or counteracting the
deadly effects of biological weapons; with this information, we could
facilitate prompt shipment of the devices as needed;
Facilitate the recall of devices marketed by owners or
operators of device establishments;
Identify and catalogue marketed devices;
Administer our postmarketing surveillance programs for
devices;
Identify devices marketed in violation of the law;
Identify and control devices imported or offered for
import into the country from foreign establishments; and
Schedule and plan inspections of registered establishments
under section 704 of the FD&C Act (21 U.S.C. 374).
We also rely on registration and listing information to help us
comply with several other statutory provisions. For example, we use
this information to generate accurate estimates of the number of
businesses that are affected by our rulemaking activities. These
estimates help us assess the impact of our regulations on regulated
industry, which we are required to do under the Regulatory Flexibility
Act of 1980 (Public Law 96-354) (5 U.S.C. 601-612), as amended by the
Small Business Regulatory Enforcement Fairness Act of 1996 (Title II of
Public Law 104-121); the Unfunded Mandates Reform Act of 1995 (Public
Law 104-4) (2 U.S.C. 1501 et seq.); the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520); Executive Order 12866 (September 30,
1993); and the Congressional Review Act (section 251 of Public Law 104-
121).
Registration and listing information will continue to be used for
all of the important public health purposes outlined previously. The
electronic submission of registration and listing information allows us
to use such information more quickly and effectively to carry out all
of the activities described previously.
In addition, electronic submission of registration and listing
information furthers the purpose of the Government Paperwork
Elimination Act of 1998 (Public Law 105-277, Title XVII) (GPEA). GPEA
requires Federal agencies to give persons who are required to maintain,
submit, or disclose information, the option of doing so electronically
when practicable as a substitute for paper, and to use electronic
authentication (electronic signature) methods to verify the identity of
the sender and the integrity of the electronic content. We believe that
electronic submission of registration and listing information furthers
the purpose of this law and makes the registration and listing
processes more efficient and effective both for industry and us.
II. Summary of Current Registration and Listing Requirements
A. Summary of Section 510 of the FD&C Act (21 U.S.C. 360)
Section 510 of the FD&C Act contains the statutory requirements
pertaining to device registration and listing. Section 510(b), (c), and
(d) of the FD&C Act address registration obligations that apply to
domestic establishments. Section 510(c) of the FD&C Act includes the
requirement for owners or operators to immediately register their
establishment ``upon first engaging in the manufacture, preparation,
propagation, compounding, or processing of * * * device or devices.''
As clarified in section 510(a)(1) of the FD&C Act, the term
``manufacture, preparation, propagation, compounding, or processing''
as used in section 510 is intended to be rather broad and also includes
``repackaging or otherwise changing the container, wrapper, or labeling
of any * * * device package in furtherance of the distribution of the *
* * device from the original place of manufacture to the person who
makes final delivery or sale to the ultimate consumer or user.''
In addition to the initial registration requirement in section
510(c), owners or operators of domestic device establishments are also
required to renew their registrations on an annual basis. Prior to
FDAAA, section 510(b) provided that such registration had to be
completed ``[o]n or before December 31 of each year.'' FDAAA amended
the timeframes in section 510(b) and now requires annual registration
to be performed during the 3-month period beginning on October 1 and
ending on December 31 of each year.
Section 510(d) of the FD&C Act requires an owner or operator that
has previously registered an establishment to immediately update his
registration information on file with the agency to include any
additional establishment that he owns or operates in which he begins
the ``manufacture, preparation, propagation, compounding, or
processing'' of a device or devices.
Section 510(i) of the FD&C Act contains certain registration and
listing requirements that specifically pertain to
[[Page 14512]]
foreign establishments. The owner or operator of a foreign
establishment has to register and list with FDA if the establishment is
engaged in the ``manufacture, preparation, propagation, compounding, or
processing of * * * a device that is imported or offered for import
into the United States.'' Section 510(i) specifies that the
registration and listing information must be submitted to FDA by
electronic means, and also requires the foreign establishments to
furnish, as part of their registration, ``the name of each importer of
[the establishment's] device in the United States that is known to the
establishment, and the name of each person who imports or offers for
import such * * * device to the United States for purposes of
importation.'' Prior to the passage of FDAAA, section 510(i) required
foreign establishments to complete their annual registration ``[o]n or
before December 31 of each year.'' FDAAA amended the timeframes in
section 510(i) and now requires annual registration to be performed
during the 3-month period beginning on October 1 and ending on December
31 of each year.
Section 510(g) of the FD&C Act establishes specific exemptions from
registration requirements and permits the Secretary, under section
510(g)(5), to create additional exemptions by regulation where the
Secretary finds that registration by those persons is not necessary for
the protection of public health.
Under section 510(e) of the FD&C Act, we may assign a registration
number to any person or establishment who registers. We may also
prescribe a uniform system for the identification of devices intended
for human use and require that persons who are required to list their
devices do so in accordance with such a system.
Section 510(f) of the FD&C Act is the provision governing the
public availability of registration and listing information that has
been submitted to FDA in accordance with section 510.
Section 510(j) of the FD&C Act prescribes the requirements for
device listing. Section 510(j)(1) requires every person who registers
to file, at the time of registration, a list of all devices that are
being ``manufactured, prepared, propagated, compounded, or processed by
him for commercial distribution'' and which have not been previously
listed by him or her. Section 510(j)(1) further requires that the
listing information be prepared and submitted in the ``form and manner
prescribed by the Secretary.'' Section 510(j)(2) of the FD&C Act
requires registrants to periodically update their listing information.
Prior to the passage of FDAAA, registrants were required to update
their device listings two times each year, once in June and once in
December. As amended by FDAAA, section 510(j)(2) now requires device
listing information to be updated only once each year during the period
beginning on October 1 and ending on December 31, which is the same 3-
month period during which establishments are required to complete their
annual registration.
Section 510(p) of the FD&C Act, as amended by FDAAA, requires the
electronic submission of device registration and listing information
unless the Secretary grants a request for a waiver because use of
electronic means is not reasonable for the person requesting the
waiver.
On October 8, 2009, FDA published the document ``Guidance for
Industry and FDA Staff--Implementation of Medical Device Establishment
Registration and Device Listing Requirements Established by the Food
and Drug Administration Amendments Act of 2007.'' The purpose of the
Guidance is to explain changes in the device registration and listing
program that are required by Section 207 of the Medical Device User Fee
and Modernization Act of 2002 and the Food and Drug Administration
Amendments Act of 2007. Copies of the guidance can be found on the
Internet at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm185871.htm.
B. Summary of Current Registration and Listing Regulations
1. Who Must Register and List Under the Current Regulations?
Under current part 807 (21 CFR part 807) of FDA's regulations, with
certain exceptions, owners or operators of establishments that engage
in the manufacture, preparation, propagation, compounding, assembly, or
processing of a device intended for human use must, in addition to
other requirements, register their establishments and submit listing
information for each of their devices in commercial distribution. FDA
has interpreted the types of establishments that must register and/or
list to include, among others, manufacturers, contract manufacturers
and contract sterilizers (currently required to register and list only
if they also distribute the device commercially on behalf of the party
initiating the specifications), specification developers,
remanufactures, repackages, re labelers, single-use device (SUD)
preprocessors, and initial importers (these parties are currently
required to register but need not submit listing information). Foreign
device establishments that manufacture, prepare, propagate, compound,
process or export a device that is imported or offered for import into
the United States also must comply with the registration and listing
requirements, including the requirement to identify a U.S. agent. The
current regulations provide for all registration and listing
information to be submitted to us using paper forms FDA 2891,
Registration of Device Establishment; FDA 2891a, Annual Registration of
Device Establishment; and FDA 2892, Device Listing, as required by
Sec. 807.22.
2. What Are the Registration Requirements Under the Current
Regulations?
The existing regulations in part 807 contain various provisions
governing the requirements for registration. Among others, those
provisions include the following:
Section 807.21(a) requires owners or operators of
establishments entering into the manufacture, preparation, propagation,
compounding, assembly, or processing of a device or devices to register
their establishment within 30 days after beginning such an activity at
their establishment.
Sections 807.25 and 807.40 describe the information
required to be submitted by owners or operators of domestic and foreign
establishments as part of their registration. This information
includes:
The names of the registered establishment, its owner or
operator, and its official correspondent;
Contact information for the official correspondent;
Trade names used by the establishment;
The types of operations or activities conducted at the
establishment; and
The name and contact information for their designated U.S.
agent (applies only to foreign establishments).
Section 807.21(a) requires owners or operators to renew
their establishment's registration on an annual basis in accordance
with a schedule specified in the regulations.
Section 807.35 provides for FDA to assign a permanent
registration number to each establishment after reviewing the
information provided to us on Form FDA 2891 at the time of the
establishment's initial registration.
3. What Are the Listing Requirements Under the Current Regulations?
The listing provisions currently found in part 807 include, among
others, the following:
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Owners or operators of establishments must, at the time of
registration, submit a list of devices being manufactured or processed
at the establishment that are in commercial distribution at that time
using forms) FDA 2892 (Sec. 807.21(a)).
The device listing information required to be submitted to
us under Sec. 807.25(f) includes, but is not limited to the
classification name and number for the device (in practice, the product
code assigned to the device by FDA is ordinarily provided rather than
the classification name and number); the proprietary and common names
associated with the device; the name and FDA-assigned identification
number of the owner or operator; the name, registration number, and
establishment type of all establishments under the joint ownership and
control of the owner or operator at which the device is manufactured,
repackaged, or re labeled; the number assigned by FDA to an approved
application for each device listed that is subject to pre market review
under section 505 of the FD&C Act (21 U.S.C. 355) or section 515 of the
FD&C Act (21 U.S.C. 360e) (in practice, the owners and operators are
also providing 510(k) clearance and Humanitarian Device Exemption (HDE)
numbers); the reason for the submission (e.g., represents a new device
listing, an update to an existing listing, or the device is being
discontinued); and if the listing relates to a previously listed
device, as in the case of an update, the initial listing number for the
device.
The current regulations at Sec. 807.30(b) require owners
or operators to update their device listing information twice each year
during June and December, or at their discretion, at the time the
change occurs. Updated information must include, but need not be
limited to:
A list of each device introduced by the registrant for
commercial distribution that has not been included in any previously-
submitted list;
All previously-listed devices for which commercial
distribution has been discontinued;
A list of all devices for which a notice of discontinuance
was submitted and for which commercial distribution has since that time
been resumed; and
Information about any other material change to listed
products, as required under current Sec. 807.30(b).
4. Who Is Not Covered by Registration and Listing Requirements Under
the Current Regulation?
Under the current regulations, certain establishments are exempt
from the registration and listing requirements set forth in part 807.
Section 510(g) of the FD&C Act, which establishes certain exemptions
from registration requirements, authorized FDA to exempt additional
classes of persons from registration requirements by regulation when we
determine that registration by those persons is not necessary for the
protection of the public health. (21 U.S.C. 360(g)). These exemptions
are reflected in our regulations at Sec. 807.65. Section 807.65
provides an exemption from registration requirements for the following
types of establishments:
A manufacturer of raw materials or components;
A manufacturer of veterinary devices;
A manufacturer of common and widely-used laboratory
equipment and/or chemical reagents not labeled or promoted for medical
use; and
Carriers whose business it is to transport and deliver
devices.
Section 807.65 further exempts from registration requirements the
following types of establishments, provided they are domestic
establishments:
Licensed practitioners, including physicians, dentists,
and optometrists, who manufacture or otherwise alter devices solely for
use in their professional practice;
Persons who manufacture, prepare, propagate, compound or
process devices solely for use in research, teaching, or analysis, and
do not introduce such devices into commercial distribution;
Pharmacies, surgical supply outlets, or other similar
retail establishments making final delivery or sale to the ultimate
user; and
Persons who dispense previously-manufactured devices or
render services to the ultimate consumer (i.e., patient, physician,
layman, etc.), such as a hearing aid dispenser, optician, clinical
laboratory, assembler of diagnostic x-ray systems, as well as personnel
from a hospital, clinic, dental laboratory, orthoepic or prosthetic
retail facility whose primary responsibility to the ultimate consumer
is to dispense or provide a service through the use of a previously
manufactured device.
Additionally, under current Sec. 807.20(c), establishment
registration and device listing requirements do not apply to any person
who:
Manufactures the device for another party who initiated
the specifications and distributes the device;
Sterilizes the device on a contract basis for another
party who distributes the device; or
Acts only as a wholesale distributor and does not
manufacture, repackage, process, or re label the device.
5. Do the Current Regulations Permit the Disclosure of Registration and
Listing Information?
Section 807.37 of the current regulations addresses the extent to
which registration and listing information submitted to us will be
available for public disclosure and the procedure for obtaining access
to such information. Specifically, that provision states that all
registration information submitted by an establishment on forms FDA
2891 and FDA 2891a will be made available for inspection at the CDRH
Office of Compliance in Maryland and also at the district office that
has responsibility for that establishment. In practice, these documents
are no longer kept at the district offices, but can still be requested
from the Office of Compliance. Registration data also can be searched
and downloaded from CDRH's Web site at www.fda.gov/cdrh.
Device listing information submitted on Form FDA 2892 may also be
requested as specified in current Sec. 807.37(b). Listing information
can also be searched and downloaded from CDRH's Web site. The search
and download capabilities of the Web-based database is the method of
obtaining registration and listing data that is most often used by the
public.
III. Highlights of the Proposed Changes to the Current Registration and
Listing Requirements
This proposal would modify the current registration and listing
regulations to reflect FDAAA's mandate that device registration and
listing be submitted electronically and to facilitate the government's
collection of additional registration information as mandated by the
Bioterrorism Act. It also would revise certain registration and listing
provisions to improve the quality of registration and listing
information that will be available to FDA for use in pursuing its
important health objectives.
Proposed Changes to the Current Registration and Listing Regulations
We are proposing the following changes to the current registration
and listing regulations:
1. Switch to an Electronic Registration and Listing System
The current regulations in part 807 require owners and operators of
device establishments to submit their registration and listing
information to FDA using paper forms (Forms FDA 2891, FDA 2891a, and
FDA 2892). This proposal would update the regulations to conform to the
requirement in section 510(p) of the FD&C Act, as amended by
[[Page 14514]]
FDAAA, that such information be provided to FDA electronically unless
FDA grants a request for a waiver.
As part of the new electronic registration and listing system, each
owner or operator establish an account using the FURLS, from which the
owner or operator creates and updates his or her establishment
registration and device listing information. Information submitted to
FDA prior to September 15, 2007, has already been migrated to the new
electronic database and thus there is no need for owners or operators
to reenter this information.
In accordance with section 510 of the FD&C Act, as amended by
sections 222 through 224 of FDAAA, device establishment owners and
operators have been using FURLS to submit their establishment
registration and device listing information electronically since the
system became operational on October 1, 2007. In addition, in
accordance with section 510(p), as amended by FDAAA section 224, FDA is
granting waivers from the new electronic submission requirements only
to those owners or operators for whom electronic registration and
listing is not reasonable.
2. Foreign Establishment Registration and Listing Requirements of the
Bioterrorism Act
Before its devices will be allowed into the United States, each
foreign establishment that is required to register must supply to FDA
the registration information required by part 807, including the name
and contact information for its U.S. agent. Section 321 of the
Bioterrorism Act affected foreign establishment registration in part by
amending section 510(i) of the FD&C Act to require, as part of an
establishment's registration, the name of each importer of the device
that is known to the establishment and the name of each person who
imports or offers to import the device into the United States. This
proposal would amend part 807 to reflect in our regulations the
Bioterrorism Act requirement that foreign establishments whose devices
are imported or offered for import into the United States must
identify: (1) All importers known to the foreign establishment and (2)
the name of each person who imports or offers to import the foreign
establishment's device into the United States. Proposed changes to
Sec. 807.3 also would add specific definitions for these two new
categories of information that need to be submitted by foreign
establishments.
On August 29, 2006, FDA issued a proposed rule (71 FR 51276)
relating to drugs (including certain blood products) which proposed to
revoke exemptions from registration and listing requirements found in
Sec. Sec. 207.40(a) and 607.40(a) (21 CFR 207.40(a) and 607.40(a))
relating to foreign establishments whose drug products enter a foreign
trade zone and are then re-exported from the foreign trade zone without
having entered U.S. commerce. The same rule also proposed to revoke
exemptions in Sec. Sec. 207.40(b) and 607.40(b) which allow a
component of a drug imported under section 801(d)(3) of the FD&Act (or
a blood product imported under section 801(d)(4) of the FD&C Act) to be
imported or offered for import into the United States even if the
component is not listed and manufactured, prepared, propagated,
compounded, or processed at a registered foreign establishment. (21
U.S.C. 381(d)(3) and (d)(4)).
Consistent with the revisions proposed to Sec. Sec. 207.40 and
607.40, and for the reasons discussed in that rule (see 71 FR 51283-
51284 and 51324), we are proposing to eliminate the exemption in Sec.
807.40(a) for foreign establishments whose devices enter a foreign
trade zone and are re-exported from the foreign trade zone without
entering U.S. commerce, and the exemption in Sec. 807.40(c) for
devices that are imported under section 801(d)(3) of the FD&C Act (21
U.S.C. 381(d)(3)). We believe that removing the exemptions from
registration and listing requirements for devices entering foreign
trade zones and for products imported under section 801(d)(3) of the
Act is consistent with Congress' desire, as reflected in the
Bioterrorism Act, to increase the Nation's ability to prepare for and
effectively respond to bioterrorism and other public health emergencies
by requiring foreign establishments to provide more, rather than less,
information for imported products.
3. Change in Requirements Relating to Contract Manufacturers and
Sterilizers
The proposed regulation would amend current part 807 regarding the
applicability of registration and listing requirements to contract
manufacturers and contract sterilizers. Under the proposed regulation,
all contract manufacturers and sterilizers would be required to
register their establishment and list their devices. Currently Sec.
807.20(a)(2) states that contract manufacturers who do not put the
device into commercial distribution do not have to list those devices.
In addition, Sec. 807.20(c)(1) and (c)(2) currently provide that
contract manufacturers and sterilizers who do not put a device into
commercial distribution do not have to register or list. These two
provisions, taken together, have been interpreted as requiring contract
manufacturers and sterilizers to register and list only if they
distribute the device commercially on behalf of the person initiating
the specifications.
FDA relies on having a complete and accurate registration of device
establishments and the devices processed at those establishments in
order to accomplish a number of important statutory and regulatory
objectives. FDA's recent experience with contract manufacturers and
contract sterilizers since October 1, 2007, suggests that many of these
firms that have voluntarily registered and listed in the past, no
longer do so. When such establishments experience a problem, it can
have significant impact on the product lines for the one or multiple
firms for which it is contracted to provide manufacturing or
sterilization services. Knowing which products are manufactured or
sterilized at the affected site could facilitate the recall of the
impacted devices. FDA also believes that knowing that these
manufacturing sites exist would be critical information when a device
is in short supply or needed in the event of a national emergency.
We are proposing to modify Sec. 807.20(a)(2) and delete Sec.
807.20(c)(1) and (c)(2) such that all contract manufacturers and
contract sterilizers would be required to register their establishments
and list their devices regardless of whether they put the device in
commercial distribution.
4. Requiring Submission of the FDA Product Code Assigned to a Device
Rather Than the Classification Name and Number
Current Sec. 807.25(f)(1) indicates that when listing their
devices, registrants need to provide, among other information, the
classification name and number of each device. The new electronic
system would require exempt devices to be identified by product code
rather than by classification name and number. The product code is
already requested for such devices. This change to the regulation,
therefore, is intended to codify the existing practice.
5. Requiring Submission of the 510(k) or HDE Number for Non-Exempt
Device Listings
Current Sec. 807.25(f)(3) requires owners or operators to provide
as part of their device listing information the premarket submission
number assigned by FDA under section 505 or 515 of the FD&C Act (21
U.S.C. 360j) for approved
[[Page 14515]]
devices. FDA also has been requesting owners or operators to identify
as part of their device listing information the assigned premarket
notification number for a device cleared under section 510(k) of the
FD&C Act (i.e., the 510(k) number) or the assigned HDE number for a
device approved for marketing under section 520(m) of the FD&C Act.
This proposal amends Sec. 807.25(f)(3) (at proposed Sec.
807.25(g)(4)) to include 510(k) numbers and HDE numbers among the types
of premarket submission numbers required to be provided as part of the
listing information submitted to FDA for non-exempt devices.
Collection of the premarket submission numbers allows FDA to better
protect the public health by providing a mechanism FDA can use to
follow the total product life cycle of non-exempt medical devices.
Having access to this information through the listing process also
facilitates the agency's use of information that was collected during
premarket review to identify devices by attributes other than the
product code that is assigned to the product. This would include
information such as whether the device contains materials from animal
sources, is an implanted device, and other information that generally
is not collected as part of the device listing.
Until FDA began collecting the 510(k) number, it was difficult to
determine which products listed under registration and listing
requirements were being marketed under a specific premarket
notification clearance. At times, the product code assigned to a device
during the premarket notification clearance process was not accurately
identified when the device was listed. This meant that a device
assigned one product code during the 510(k) review process could
ultimately be listed with FDA under a different product code once the
device was put in commercial distribution.
This lack of a direct link between products on the market and their
premarket filings made it difficult for FDA to know which devices that
we had cleared were being marketed, and where the devices were being
marketed. This change would allow us to better identify, evaluate, and
resolve potential problems with marketed devices when public health
concerns arise.
Proposed Sec. 807.25(g)(4) would codify the practice of including
the 510(k) number when listing a medical device that has gone through
premarket clearance or the approved HDE number in the electronic device
registration and listing system. This change also would provide FDA
with a tool to help ensure that devices that lack a required premarket
clearance or premarket approval are not marketed.
6. Identification of a Contact Person to Administer the Electronic
System Accounts
Prior to the implementation of FURLS, each owner or operator
identified an official correspondent on Forms FDA 2891 and FDA 2891a.
The official correspondent was the only person who could supply, delete
or change information related to a device establishment and its
listings. As a result of the passage of FDAAA, FDA began collecting
device registration and listing information using FURLS beginning in
October 2007. When using FURLS, an owner or operator needs to identify
not only an official correspondent for the establishment but also a
contact person for the owner or operator. The contact person is the
only person who can administer the owner or operator's user accounts in
FURLS.
In instances where owners or operators have only one establishment,
they may choose the same person to serve as both the contact person for
the user account and the official correspondent for the establishment.
For owners or operators with multiple establishments, the contact
person for the owner or operator may also serve as the official
correspondent for any or all of the owner or operator's establishments.
Alternatively, using the accounts management software for FURLS, the
owner or operator may create subaccounts in which different official
correspondents are identified for each establishment.
Proper control of access to accounts and control of the ability to
update an establishment's online information is necessary to avoid
errors. Therefore, we are proposing that each owner or operator
identify only one contact person within the owner or operator's
organization who will be responsible for creating the master account in
FURLS for the owner or operator and assigning subaccounts to each
establishment, if needed. Once the contact person creates the master
account and any needed subaccounts, the official correspondent can then
use the accounts to submit the owner or operator's establishment
registration and device listing information to FDA.
7. Establishment Operations Will Be Reported Through Device Listing
Currently, owners or operators are required to identify the
operations or activities that they conduct at their establishments as
part of the registration information required on Forms FDA 2891 and FDA
2891a and also as part of the listing information required on Form FDA
2892. Under the proposed rule, we would require owners or operators to
identify the operations or activities their establishments engage in
only as part of their device listings. This is because the new
electronic system has been designed to automatically migrate the
information provided in the device listing to the owner or operator's
registration, thus saving the owner or operator from having to provide
the same information twice. Because under the new system owners or
operators would only have to supply such information once, this change
will save time and help avoid inconsistencies between the registration
and listing information for a single establishment.
8. Registration Fees
FDAAA section 212 requires that certain medical device
establishments pay a registration user fee when they initially register
with us and for each annual registration thereafter. Therefore, we are
deleting the sentence at the beginning of Sec. 807.20(b) that states,
``No registration or listing fee is required.''
9. Definition of Restricted Devices
This proposal also would revise the definition of ``restricted
device'' in Sec. 807.3(i) to more accurately reflect the provisions of
the FD&C Act that provide us with authority to restrict devices.
IV. Description of the Proposed Rule
We are proposing to amend our establishment registration and device
listing regulations in part 807 in order to implement changes that are
required by FDAAA, section 321 of the Bioterrorism Act, and section 207
of MDUFMA.
As a result, in this proposal we have revised and re-codified some
provisions, added new provisions, and eliminated others. The following
discussion of the proposed rule describes the new provisions we would
add to part 807 and also the changes we would make to the existing
provisions.
A. General
1. What Is the Purpose of the Proposed Changes to Part 807?
Changes we are proposing to the current registration and listing
requirements are intended to:
Improve the accuracy and availability of postmarket
medical device information;
Make submission of the information required by the
registration and listing provisions of part 807 easier and faster;
Comply with the Bioterrorism Act and MDUFMA by
implementing an
[[Page 14516]]
electronic registration and listing system;
Comply with the additional information collection
requirements of the Bioterrorism Act;
Eliminate ambiguity and clarify requirements in the
current device registration and listing regulations; and
Link postmarket listing data collection with related
premarket data by collecting premarket review numbers assigned by FDA.
2. Who Would Be Affected by the Proposed Changes to Part 807?
The proposed changes to part 807 would impact all device
establishments that are required to register their establishments and
list their devices with FDA; however, the revised regulation would have
the greatest impact on contract manufacturers, contract sterilizers,
and foreign establishments.
a. Contract manufacturers and sterilizers. The proposed rule would
require that all contract manufacturers and contract sterilizers
register their establishments and list their devices. Currently, there
are two provisions, Sec. 807.20(a)(2) and (c), that address the
registration and listing requirements for contract manufacturers and
contract sterilizers. Current Sec. 807.20(a)(2) states: ``* * * person
who only manufactures devices according to another person's
specifications, for commercial distribution by the person initiating
specifications, is not required to list those devices.'' Current Sec.
807.20(c) states: ``Registration and listing requirements shall not
pertain to any person who: (1) Manufacturers devices for another party
who both initiated the specifications and commercially distributes the
device; (2) sterilizes devices on a contract basis for other registered
facilities who commercially distribute the devices. * * *''
These two provisions, taken together have been interpreted to
require registration and listing by contract manufacturers or contract
sterilizers only when they are the party placing the device into
commercial distribution. We are proposing to delete current Sec.
807.20(c)(1) and (c)(2) and, in addition, would revise Sec.
807.20(a)(2) in a manner consistent with section 737(13)(A) of the FD&C
Act (21 U.S.C. 379i(13)(A)), a provision added by FDAAA that addresses
which types of establishments are subject to device registration user
fees. These changes to Sec. 807.20(a) and (c) will have the effect of
requiring all contract manufacturers and sterilizers to register and
list regardless of whether they commercially distribute the devices.
The agency believes this approach to registration and listing for these
devices and combination products best enables effective oversight by
appropriate agency components. Having all contract manufacturers and
sterilizers register and list would provide us with basic information
about the entities that make and clean devices. This information would
allow us to respond in a more timely and effective fashion in the case
of an adverse event, shortage, or other problem associated with one of
these establishments. The information would also assist us in our
fundamental regulatory activities, such as planning and scheduling
inspections.
We recognize that with regard to combination products, this
approach to registration and listing may result in registration of the
same facility and listing of the same product with more than one agency
component. However, we also note the agency is currently working to
develop harmonized electronic registration and listing systems within
FDA. We anticipate that once these harmonized systems are in place, the
agency will be able implement a more streamlined approach to facility
registration and product listing for combination products.
(b) Foreign establishments engaged in the manufacture, preparation,
propagation, compounding, or processing of a device that is imported or
offered for import into the United States are currently required to
register and to submit listing information in accordance with section
510 of the FD&C Act and Sec. 807.40 of our regulations. These foreign
establishments are also required to designate a U.S. agent, and to
provide contact information for that person to FDA.
The revised regulation will codify requirements established by
section 222 of FDAAA, which changed the timeframes in section 510(i) of
the FD&C Act for annual registration by foreign device establishments
to a specific 3-month period each year beginning on October 1 and
ending on December 31. It also would codify in part 807 certain
requirements established by section 321 of the Bioterrorism Act. The
Bioterrorism Act amended section 510(i) of the FD&C Act to require
those foreign establishments that have to register with FDA to do so by
electronic means, and to include additional pieces of information as
part of their registration. The additional information required by
section 510(i) includes the name of each ``importer of such * * *
device in the United States that is known to the establishment,'' and
the name of each ``person who imports or offers for import such * * *
device to the United States for purposes of importation.'' As discussed
at section IV.A.4 of this document, this proposal also would
incorporate, at Sec. 807.3, definitions clarifying these two new
categories of information that need to be submitted by foreign
establishments.
Most of the provisions in section 321 of the Bioterrorism Act
became effective on December 8, 2002, but the effective date of the
electronic registration requirement was later delayed by MDUFMA section
207 (which added section 510(p) of the FD&C Act) so that FDA would have
an opportunity to put systems in place to accommodate the electronic
receipt of registration information. The agency has now developed a
system, FURLS, which became operational on October 1, 2007, that makes
the electronic receipt of device establishment registration and device
listing information feasible.
3. Who Would Be Exempt From Registration and Listing?
We propose no changes to the categories of persons or
establishments that are exempt from registration requirements under
Sec. 807.65. As discussed in section IV.A.2.a. of this document,
however, we are proposing to eliminate the exemption from listing
requirements for contract manufacturers under Sec. 807.20(a), and the
exemption from registration and listing requirements for contract
manufacturers and contract sterilizers under Sec. 807.20(c)(1) and
(c)(2). As a result, all contract manufacturers and sterilizers would
need to register and list regardless of whether they put the devices
into commercial distribution.
For the same reasons as stated in the proposed revisions to part
207 of FDA's regulations addressing drug establishment registration and
listing, which were published in the Federal Register of August 29,
2006 (71 FR 51276), we are proposing to revoke exemptions in current
Sec. 807.40(a) relating to foreign establishments whose devices enter
a foreign trade zone and are re-exported from that foreign trade zone
without having entered U.S. commerce, and in Sec. 807.40(c) regarding
devices that are imported into the United States under section
801(d)(3) of the FD&C Act for further processing and then exported
without having been placed on the U.S. market. We propose eliminating
these two exemptions because of certain statutory changes that have
occurred since the publication of the final rule on foreign
establishment registration and listing. Those changes include enactment
of the Bioterrorism Act, which reflects Congress' desire to
[[Page 14517]]
increase the nation's ability to prepare for and respond effectively to
bioterrorism and other public health emergencies and Congressional
findings that greater controls over imported products be part of that
effort.
4. What Definitions and Interpretations of Terms Would Apply to Part
807?
In proposed Sec. 807.3, we set forth new definitions and
interpretations of terms as follows:
a. We are proposing to add a definition for the term Product Code
at Sec. 807.3(k) to help describe the identifying information that
would have to be submitted when listing a medical device that is exempt
from premarket notification requirements. Currently, the product code
is a three-letter code used by FDA to identify the generic category of
a device. Section 807.25(f)(1) of our regulations currently states that
the owner or operator must identify the classification name and number
when providing device listing information. In practice, however, CDRH
instead has requested and accepted the three-letter product code which
can be identified from the Web-based medical device classification
database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
b. Proposed Sec. 807.3(v) includes a definition for FURLS, which
as stated previously, stands for FDA Unified Registration and Listing
System. FURLS is the Internet-based electronic system that owners and
operators of device establishments must use to submit device
registration and listing information to FDA.
c. As described more fully in section IV.B.3 of this document, this
proposal would help to implement the requirement in section 510(i) of
the FD&C Act, as amended by the Bioterrorism Act, that a foreign
establishment engaged in the manufacture, preparation, propagation,
compounding, or processing of a device that is imported or offered for
import into the United States provide as part of its registration with
FDA identifying information for each importer of such device that is
known to the establishment. In proposed Sec. 807.3(x), we are
proposing to define the term ``importer'' to mean a company or
individual in the United States that is an owner, consignee, or
recipient of the foreign establishment's device that is imported into
the United States. We recognize that a foreign establishment may have
more than one ``importer'' and we are proposing to include in this term
any owner, consignee, or recipient, even if not the initial owner,
consignee, or recipient, of the foreign establishment's device that is
imported into the United States. Under this proposal, the term
``importer'' would not include the consumer or patient who ultimately
purchases, receives, or is the end user of the device, unless the
foreign establishment ships the device directly to the consumer or
patient. We invite comments on our definition of importer, including
the scope of the entities included in the definition.
d. Section 510(i) of the FD&C Act, as amended by the Bioterrorism
Act, also requires that foreign establishments who are required to
register with FDA identify as part of their registration information
each ``person who imports or offers for import'' the establishments'
devices to the United States. This requirement, which would be
implemented at proposed Sec. 807.41, is discussed further in section
IV.B.3 of this document. In addition, we are proposing a separate
definition for the term ``person who imports or offers for import'' at
Sec. 807.3(y). As defined, this term would include an agent, broker,
or other entity, that the foreign establishment uses to facilitate the
importation of its device into the United States. However, consistent
with the legislative history of the Bioterrorism Act, the term ``person
who imports or offers for import'' would not include carriers. We
invite comments on our proposed definition of the term ``person who
imports or offers for import.''
B. Registration
1. Who Would Be Required To Register?
Section 510(b) of the FD&C Act states that registration
requirements apply to owners and operators of establishments engaged in
the ``manufacture, preparation, propagation, compounding, or processing
of medical devices.'' Section 510(a)(1) of the FD&C Act defines these
terms to include ``repackaging or otherwise changing the container,
wrapper or labeling of any device package in furtherance of the
distribution of the device * * *''.
The revisions we are proposing would not change the classes of
persons required to register, except to specify that all contract
manufacturers and sterilizers must register their establishments,
regardless of whether they put the device in commercial distribution or
instead return it to the specification developer or point of origin.
2. When Would Initial Registration Information Need to Be Provided?
Section 807.21, the provision specifying timeframes for
establishment registration, is being renumbered in this proposal to
Sec. 807.22. Proposed Sec. 807.22 would retain the requirement that
owners or operators must register each establishment no later than 30
calendar days after entering into an activity that triggers
registration requirements under part 807.
Under current Sec. 807.40(c), with certain limited exceptions, a
foreign owner or operator must register an establishment before a
device manufactured at the establishment may be imported or offered for
import into the United States. This proposal would not change the
timeframe for initial registration by a foreign establishment.
3. What Information Would Be Required for Registration?
Under proposed Sec. 807.25, all owners or operators would need to
provide the following information in order to register their
establishments:
a. Name of the owner or operator of each establishment. Section
807.3(f) defines the owner or operator as the corporation, subsidiary,
affiliated company, partnership, or proprietor directly responsible for
the activities of the registering establishment. While the requirement
to identify the owner or operator of the establishment is not new, we
are addressing it here to provide assistance in identifying the owner
or operator for medical device registration and listing purposes.
In practice, the owner or operator usually is the entity that has
final responsibility over the device establishment, such as the
establishment's parent company or corporate headquarters. For most
small device manufacturers who conduct their business activities at the
same site as their regulated device activities, this typically is the
same name and address as that of the registered establishment itself.
In other words, for a business that has only one location where all
medical device production activities are conducted and where corporate
responsibility for those activities resides, the owner or operator name
and address information is the same as the establishment information.
This has often been a source of confusion regarding the information
that must be submitted for registration and listing. We invite comments
and questions about what constitutes the ``owner or operator'' of a
device establishment for purposes of part 807.
b. Name, trade name(s), and address of each establishment (proposed
Sec. 807.25(b)). This provision is consistent with section 510(c) of
the FD&C Act, which requires owners and operators to register the names
and place of business of the establishment. There are no
[[Page 14518]]
changes being proposed to this requirement in the revised regulation.
c. Registration number of each establishment. Section 510(e) of the
FD&C Act authorizes us to assign a registration number to any person or
establishment who registers. Under Sec. 807.35(a) of our regulations,
we currently assign a permanent registration number to each device
establishment when that establishment registers for the first time. The
proposed regulation would only change the method of delivery of the FDA
registration number to the owner or operator. FDA registration numbers
are communicated to the registrant by email after we receive the
registration information through the electronic device registration and
listing system and it has been verified by the appropriate FDA district
office. As there is no physical document to validate and return, FDA no
longer sends a validated copy of a form back to the registrant by
postal mail.
d. Name, address, telephone and fax numbers, and e-mail address of
the official correspondent for each establishment (proposed Sec.
807.25(e)). In this document, we continue to require information
regarding the official correspondent of the establishment because we
need a contact person to be responsible for submitting and keeping the
establishment's registration and device listing information current,
and to facilitate contact between FDA and the owner or operator. Under
proposed Sec. 807.25(e), this information must be kept current and any
change in this information must be provided to us within 30 calendar
days.
e. Information for foreign establishments only. With respect to
foreign establishments who are required to register their establishment
with FDA, we would require under proposed Sec. Sec. 807.40 and 807.41,
that such establishments submit the name, address, telephone and fax
numbers, and e-mail address for the following:
The U.S. agent;
Each importer of the establishment's device in the United
States that is known to the establishment; and
Each person who imports or offers for import the
establishment's device to the United States.
The name, address, and phone number of the United States agent is
information that already must be submitted under current Sec.
807.40(c). We are proposing that owners or operators also be required
to provide information regarding importers and persons who import or
offer for import the foreign establishment's device because of changes
made to section 510(i) of the FD&C Act by section 321 of the
Bioterrorism Act. Section 510(i), as amended, requires foreign
establishments to submit as part of their annual registration, among
other things, the name of each ``importer'' of their device that is
known to the foreign establishment and also the name of each ``person
who imports or offers for import'' the foreign establishment's device
to the United States. We, therefore, expect the person responsible for
providing the registration and listing information on behalf of the
foreign establishment to undertake appropriate due diligence in
gathering and entering the information, which would include identifying
and reporting those importers that others in his or her establishment
know of or have reason to know of. In addition to identifying them by
name, the proposal would require that the foreign establishment provide
the address, telephone and fax numbers, and e-mail address of each
importer and each person who imports or offers for import to enable us
to contact these persons.
We expect that some of the foreign establishments' ``importers''
will be parties who also are considered ``initial importers'' as that
term is defined in our current registration and listing regulations at
Sec. 807.3(g). Under Sec. 807.3(g), the term initial importer means
any importer who furthers the marketing of a device from a foreign
manufacturer to the person who makes the final delivery or sale of the
device to the ultimate consumer or user, but does not repackage, or
otherwise change the wrapper or labeling of the device of device
package. Because initial importers are already required to register,
the electronic registration and listing system will permit foreign
establishments to use a search mechanism built into the system to
identify those importers of the foreign establishment's devices that
are also initial importers. Foreign establishments providing
information for other types of importers such as retail establishments
and end users who are not ordinarily required to register with FDA
would have to provide the name, address and contact information for
each such importer, except they would not need to identify an end user
that is either a consumer or patient, unless the foreign establishment
ships its product directly to the consumer or patient.
Because foreign establishments may use different importers and
persons who import or offer for import for different devices, in order
to collect this information efficiently, the agency proposes to have
foreign establishments provide this information when they are listing
their devices. The electronic system will provide an interface for the
foreign establishment to identify each product's importers and persons
who import or offer for import on a listing-by-listing basis.
The foreign establishment would not be considered registered until
all information required under proposed Sec. Sec. 807.25, 807.40 and
807.41 is submitted. Foreign establishment registration data collected
through the electronic registration and listing system will allow us to
accurately identify who is making devices, where they are being made,
and where they are going within the United States. Having this
information is critically important to the nation's ability to prepare
for and effectively respond to public health emergencies, including
bioterrorism threats and other public health emergencies.
4. What Are the Proposed Requirements for Reviewing and Updating
Registration Information?
This proposal would modify and streamline the requirements
associated with updating registration information. Currently, the
regulations require that owners or operators submit changes to their
establishment registration information on Form FDA 2891a at the time of
annual registration, or by letter if the changes occur at other times.
Under proposed Sec. 807.22, establishments would access FURLS and
review their current registration information online, making changes
only where needed. Updating registration information is less time
consuming using FURLS because the establishment's current information
is easily accessible at all times and only changes to the information
already in the system need to be entered into the applicable fields.
Previously, the registration and listing forms required that most or
all of an establishment's registration and/or device listing
information be re-entered on each paper form submitted to FDA.
Some of the specific requirements proposed for updating
registration information include the following:
a. Updates of registration information. Owners or operators, under
proposed Sec. 807.25, would report the following changes no later than
30 calendar days after the change occurs:
The closing or sale of an establishment;
Any change in the name or address of an establishment;
Any change in the name or address of the owner or
operator; and
Any change in the name, address, telephone and fax
numbers, or e-mail
[[Page 14519]]
address of the official correspondent or the U.S. agent.
We encourage establishments to provide expedited updates as soon as
possible after the change occurs, which the new electronic device
registration and listing system will facilitate, but no later than 30
calendar days after the change occurs.
b. Annual review and update of registration information. Proposed
Sec. 807.22 would require that registration information be reviewed
and updated annually, during the period beginning on October 1 and
ending on December 31, which represents the first 3 months of FDA's
fiscal year. This timeframe is consistent with the requirements in
section 510(b) and (i) of the FD&C Act as amended by section 222 of
FDAAA. Current Sec. 807.21 provides a schedule for the annual
registration of establishments during one of four periods of the
calendar year (i.e., March, June, August, and November) based on the
first letter of the owner or operator's name. Proposed Sec. 807.22
would replace this schedule with the requirement that all owners or
operators renew their registration information annually, during the
period beginning on October 1 and ending on December 31 of the fiscal
year for which they are registering.
All registration information would need to be reviewed and updated
each year using FURLS, even when no changes have occurred during the
previous year. The phrase ``review and update'' as used in proposed
Sec. 807.22(b) stresses the importance of first reviewing all
registration information to determine if any changes have occurred, and
then updating the information where needed, or confirming the accuracy
of the current information. Under proposed Sec. 807.22, updates must
reflect all changes that have occurred since the last update.
When an owner or operator fails to comply with the annual
registration or listing requirements, the establishment converts to a
``failed to register'' or ``failed to list'' status as applicable. This
would include registrants who have not been granted a waiver from
electronic registration who attempt to re-register their establishment
by submitting a paper-based form or letter. These establishments would
retain their failed to register and/or list status until the owner or
operator uses the electronic system to review, update, and certify the
accuracy of their registration and listing information.
We believe that placing establishments whose owners or operators
fail to comply with registration or listing requirements in one or both
of these categories, as applicable, is reasonable given the importance
of registration and listing information. To increase the nation's
ability to prepare for and respond effectively to public health
emergencies, including bioterrorism threats and other public health
emergencies, it is becoming increasingly important for owners and
operators of device establishments to comply with our registration and
listing requirements. With accurate registration and listing
information, FDA can more quickly identify where particular types of
devices, e.g., respirators or blood tubing, are being made and help
ensure that they are available as promptly as possible for a public
health emergency. Furthermore, taking steps to increase compliance with
these requirements is consistent with section 301(p) of the FD&C Act
(21 U.S.C. 331(p)), which makes it a prohibited act to fail to register
or list in accordance with section 510 of the FD&C Act.
c. Type of operation. We are proposing to have owners or operators
enter information about the types of operations or activities conducted
at each of their establishments only when they are entering listing
information. Before the implementation of FURLS, changing the types of
operations or activities required updates to both registration and
listing data. This has in some instances led to discrepancies between
the types of activities being reported on an establishment's
registration forms as compared to the activities being reported on
their device listing forms.
FURLS automatically keeps an establishment's registration record
current and consistent with its listing information by assigning or
removing activities to and from the registration record based on the
current active listing information for each device. This practice will
help to avoid confusion and conflicts between registration and listing
information for a single establishment.
d. How the information would be submitted. Proposed Sec. 807.21
would require establishments to submit information to us
electronically, unless we grant a waiver under proposed Sec.
807.21(b).
e. Transfer of device establishment ownership. Under this proposal,
information regarding changes to ownership of device establishments
would also be submitted using the electronic device registration and
listing system. There would be a selection from the main menu that will
appear for the device registration and listing system when accessed
through FURLS that will prompt the user through the process of
submitting all information required to report the transfer of
ownership.
C. Listing
1. Who Would Be Required to List Devices?
The changes we are proposing would not change the classes of
persons that are required to list devices, except to alter the listing
obligations of those contract manufacturers and sterilizers who are
currently exempt from listing under Sec. 807.20(a)(2), (c)(1), and
(c)(2) because the establishments for whom they make or sterilize
devices on a contract basis are the ones who commercially distribute
the devices. As stated elsewhere in this document, we are proposing to
eliminate this exemption, which will have the effect of requiring all
contract manufacturers and contract sterilizers to register and list
regardless of who has responsibility for placing the devices into
commercial distribution.
Under this proposal, all parties who are required to register would
continue to be required to also provide device listings to FDA, with
the exception of initial importers. Initial importers currently are not
required to submit a device listing for those devices for which the
initial importer did not initiate or develop the specifications, or
repackage or relabel the device. We are not proposing to change this
practice.
2. When Would Listing Information Be Provided?
Under proposed Sec. 807.22(a), at the time an establishment is
initially registered, owners and operators would list any device that
the establishment manufactures or otherwise puts in commercial
distribution. This provision is consistent with section 510(j)(1) of
the FD&C Act, which requires, among other things, that every person who
registers with the Secretary under section 510(b), (c), (d), or (i) of
the FD&C Act must, at that time, provide the Secretary with a list of
the devices being manufactured, prepared, propagated, compounded, or
processed by that person for commercial distribution.
Proposed Sec. 807.22(a) and (b) also address providing listing
information for devices not previously listed and reviewing and
updating information for devices that have already been listed.
Previously, owners or operators were required to review and update
listing information each June and December and submit all material
changes to the device listing information that had been previously
submitted.
[[Page 14520]]
Although registrants may choose to amend their device listing
information at any time throughout the year, under proposed Sec.
807.22(a) and (b), owners and operators would be required to review and
update their listing information only once per year, during the annual
registration period beginning on October 1 and ending on December 31 of
each year. In addition, foreign establishments would continue to be
required to submit device listings before their devices may be imported
or offered for import into the United States.
3. What Listing Information Would Be Required?
The following discussion summarizes the new information that would
be required under proposed Sec. Sec. 807.25, 807.26, and 807.28:
a. The assigned FDA premarket submission number of the approved
application or cleared premarket notification for each device listed
that is subject to sections 505, 510, 515, or 520 of the FD&C Act,
which includes devices that are not exempt from premarket notification
and approval. In the case of non-exempt products, owners or operators
would be required to identify a product's premarket submission number,
that is, the number FDA assigned to the 510(k), premarket approval
(PMA) application, product development protocol (PDP), humanitarian
device exemption (HDE), or new drug application (NDA). Unlike the
previous system, which assigned one listing per product code, under the
new electronic system (FURLS) each device with a premarket submission
number now constitutes a separate listing and is assigned a unique
listing number. In FURLS, when the premarket submission number is
entered, the product codes that were assigned to the premarket
submission based on the FDA premarket review are automatically
displayed. This new system helps establishments ensure that the listed
product codes match those that appear on the substantial equivalence
notification or on the premarket approval letter.
This change, which would be codified in Sec. 807.25(g)(4),
generates more unique listing numbers than the previous system, because
individual listings are generated for each product subject to a 510(k),
PMA, PDP, HDE, or NDA.
b. Additional types of information required to be provided by
foreign establishments. With respect to foreign establishments only,
for devices manufactured, prepared, propagated, compounded, or
processed at the establishment, the establishment must identify and
provide contact information for: (1) The U.S. agent, (2) each importer
of the foreign establishment's device in the United States that is
known to the establishment (``importers''), and (3) each person who
imports or offers for import such device to the United States. The
requirement for foreign establishments to designate a U.S. agent is
already included in the current regulations at Sec. 807.40(b) and this
requirement would not change. However, the information regarding
importers and persons who import or offer for import currently is not
required to be submitted under part 807. Because section 321 of the
Bioterrorism Act requires the submission of information about importers
and persons who import or offer for import, we are proposing to amend
our regulations to conform to the statutory requirements.
In order to make it easier for foreign establishments to provide
information about importers and persons who import or offer for import
when they are registering and listing with FDA, FURLS includes an
interface that allows the foreign establishments to select their
importers from the FDA database of registered initial importers, and to
enter the names, addresses, and other contact information for any
additional importers and persons who import or offer for import (e.g.,
agents, brokers) who have not previously been entered into the
electronic database.
Several of the listing requirements in current Sec. Sec. 807.25,
807.26, and 807.28 have changed only insofar as how the information
would be submitted using FURLS. These requirements include the
following:
c. The current registration number and name of each establishment
under the ownership and control of the owner or operator that performs
a regulated function to a device. Proposed Sec. 807.25(g)(1) requires
that the owner or operator provide FDA with the registration number(s)
for all establishments under his or her ownership or control that
perform a regulated function on, to, or for a device. This means the
owner or operator does not need to inform FDA of any activity regarding
the device that is performed at an establishment that is not under the
owner or operator's ownership or control. For example, an owner or
operator that develops specifications at one establishment that is
under its ownership and control, and then manufacturers the device at
another establishment that is also under its ownership and control,
must inform FDA about both establishments when listing the device.
However, an owner or operator that develops specifications for a device
that is then manufactured by another owner or operator's establishment,
i.e., an establishment which is not under its ownership and control,
must only identify the establishment where the specifications were
developed, when submitting listing information. In this case, the owner
or operator would not need to identify the manufacturing establishment.
This requirement, while not new, has in the past been the source of
some confusion. To avoid further confusion, FURLS has been designed
such that an owner or operator can only submit listing information for
establishments under its ownership or control. Under FURLS, the owner
or operator selects their establishment(s) from a pick list that only
includes establishments under the owner or operator's control.
d. The product code for all listed devices that are exempt from
premarket notification and approval, as well as devices put into
commercial distribution prior to May 28, 1976. Under this proposal,
owners or operators listing devices that are considered exempt from
premarket notification, ``pre-amendment'' devices, (i.e., devices put
into commercial distribution prior to May 28, 1976), or devices
intended for export only, would continue to identify an applicable
product code for the device at the time of listing. When submitting
listing information using Form FDA 2892, the owner or operator had to
make the determination of which products could be listed under their
product code and did not require an FDA premarket submission number.
However, the new electronic system automatically displays only the
product codes for which an owner or operator can create an exempt or
export-only listing during the listing process, thereby eliminating the
possibility of the owner or operator selecting a product code that
requires a premarket submission.
e. The proprietary or brand name(s) under which the device is
marketed. FURLS accommodates entry of as many proprietary or brand
names as are needed for all listings. This is a change from the paper-
based system which limited the number of characters available for entry
of the proprietary or brand names. The design of the FURLS database and
Web interface allows entry of as many proprietary or brand names as may
be associated with the listing.
f. Each activity or process that is conducted on, or done to, the
device by the listing owner or operator at each establishment shown on
the listing, such as manufacturing, manufacturing for export only,
repacking, relabeling,
[[Page 14521]]
developing specifications, remanufacturing, SUD reprocessing, contract
manufacturing, or contract sterilizing. We are proposing that
information about the activities or processes that are performed with
respect to a device at each registered establishment such as
manufacturing, manufacturing for export only, repacking, relabeling,
developing specifications, remanufacturing, single-use device
reprocessing, contract manufacturing, or contract sterilizing, be
identified as a part of the listing process only. Previously, we
required such information to be submitted on the establishment
registration form (under ``Establishment Types'') and on the device
listing form. Consequently, at times there were inconsistencies between
the two forms, which led to confusion about the activities actually
being conducted at a particular device establishment at any given time,
especially as companies added new products or discontinued previously-
listed products. By limiting the submission of this information to the
listing process, the information available to FDA should become more
consistent and accurate because FURLS is designed to automatically
conform the establishment registration record to reflect any changes
made to the device listing information, including any changes in the
types of activities or processes performed at the establishment. For
example, if an owner or operator lists a product under product code ABC
as being manufactured at Establishment 1, and lists another product
under product code DEF as being repacked or relabeled at Establishment
1, then Establishment 1's registration would automatically include
manufacturing and repacking/relabeling as activities at the
establishment. If the owner or operator were to amend its listing
information to reflect that it discontinued the product under product
code DEF, the registration data for Establishment 1 would automatically
be revised to show Establishment 1 as a manufacturing site only.
We expect this will be a more efficient way to collect this
information, and should lessen the burden on the owner or operator, who
no longer would be required to enter information about the
establishment's operations during both the registration and the listing
processes. The owner or operator would no longer be responsible for
ensuring that the activities identified in their registration record
are consistent with those in their listing records because changes made
to the activities included on their listing records would automatically
update the activities on their registration record.
4. What Are the Proposed Requirements for Reviewing and Updating
Listing Information?
Previously, establishments had to enter new or revised listing
information on Form FDA 2892 and return the form to FDA. Under this
proposal, owners or operators would instead be required to access our
electronic device registration and listing system (FURLS), review their
current listing information online, and make any changes as needed.
Updating listing information is less time-consuming under the proposal
because owners or operators are able to access their information at any
time, and only need to enter data in the fields where there are changes
to listing information. It also eliminates the need to mail the form to
FDA, and eliminates the return and re-mailing of listing forms when the
information initially provided on the form was incorrect or incomplete.
The electronic system has automatic validations and edits built in to
help ensure that all listing information is complete and correct.
Under proposed Sec. 807.22(b), during the annual review and update
of registration information, establishments would be required to
provide original listing information for any device that has not been
previously listed, as well as updates to listings for devices that have
been previously listed.
Under proposed Sec. 807.22(b)(3), owners or operators would review
and update their listing information during the period beginning on
October 1 and ending on December 31 of each year. This is consistent
with the timeframes set forth in the amendments to section 510(j)(2) of
the FD&C Act by section 223 of FDAAA.
D. Electronic Format
1. How Would Registration and Listing Information Be Provided To FDA?
Under proposed Sec. 807.21, all registration and listing
information would be provided to FDA through use of our electronic
device registration and listing system, FURLS, with the exception of
labeling and advertisement information for a device (when submission of
this information is appropriate), and information from those owners and
operators who are granted a waiver from the requirement to submit
information electronically.
To register their establishment and list their devices using FURLS,
owners or operators need to do the following:
Create an account in the FURLS. If owners or operators
already have a FURLS account as a food or drug establishment, they
would update their existing FURLS account to include access to the
device registration and listing system;
Create subaccounts, as necessary, for the official
correspondent for each establishment that is being registered;
Follow the prompts and the help text provided to enter
their establishment registration and device listing information; and
Certify that the information entered is accurate and
complete.
Electronic submission of registration and listing information
provides a number of advantages over the paper-based submission
process. For example:
We receive more accurate information than with paper
submissions. The information received is more consistent and accurate
because FURLS includes validation and automated edits to help provide
consistency among the data. This also helps eliminate errors of
transcription made when we input paper-based data into our old
registration and listing database;
Both for industry and FDA, electronic transmission of the
information is easier and more efficient than the use of paper forms.
For example, users submitting information receive onscreen, real-time
feedback if the information submitted is incomplete, thereby reducing
errors and the time and cost of communicating with FDA. Electronic
transmission of the information also significantly reduces the time and
cost associated with processing paper forms and communicating with
industry about errors found on those forms; and
The registration and listing information available for
search and retrieval, both for FDA and industry, is more accurate and
up-to-date. Updates may be made to FURLS in real time as opposed to the
paper-based system where submissions could take several weeks to arrive
at FDA from foreign establishments, then require another week to 10
days to be screened at our mail facility, forwarded to our data entry
contractor, and entered in our current database.
2. How Does the Electronic Device Registration and Listing System Work?
Information that is required from owners and operators is submitted
to our electronic device registration and listing system (FURLS) over
the Internet. The system has a number of features designed to improve
the overall accuracy and verifiability of submitted information, and
decrease the burden on owners and operators to comply with
[[Page 14522]]
FDA's registration and listing regulations. The system is consistent
with conventions found on other government sites. Some key features of
the system are: (1) Our electronic device registration and listing
system (FURLS) is accessible through our FDA Internet site. To use the
Web site, you need access to the Internet using a browser. You could
arrange for Internet access through one of many available Internet
Service Providers (ISPs).You need an e-mail address so we can send you
confirmation of submissions and other related information. This e-mail
address could be obtained through the ISP or from other sources; (2)
prior to accepting registration and listing information from this
online system, we authenticate the source (that is, the owner or
operator) providing the data. We authenticate entry into the electronic
device registration and listing system by establishing user accounts
based on current registration information. We also contacted owners or
operators of currently registered establishments to identify the single
contact person who is responsible for creating and maintaining the
owner or operator's account and creating and maintaining any
subaccounts that the owner or operator may require for additional
official correspondents if more than one establishment is owned or
operated by a single entity; and (3) to register and list
electronically and to provide updates to your registration and listing
information you would go to our Web site and follow the instructional
prompts. You sign onto the system by entering the account number, user
name, and password obtained by following the procedures on the FDA Web
site and e-mailed and paper-mailed to all current owners or operators
describing our electronic device registration and listing system. You
are prompted to provide general information about the owner or operator
and then specific information about each establishment and device as
described in the provisions of proposed part 807. When all of the
required information has been provided, the official correspondent is
notified electronically that FDA has received the information.
3. Will FDA Provide Training on How to Submit Registration and Listing
Information Electronically?
We provide detailed instructions on our Web-sent e-mail and paper
mailings to registered establishments explaining FURLS. These materials
explain the electronic process for providing registration and listing
information, including step-by-step instructions on creating user
accounts and entering the information that is required under proposed
part 807.
4. What Language Would Be Used to Provide Registration and Listing
Information?
All domestic firms already submit registration to us in English
and, in this proposal, we would retain the current requirement under
Sec. 807.40(c) that foreign establishments also submit their
registration and listing information in the English language. While the
requirement has not changed, it has been renumbered as Sec. 807.40(d)
to accommodate the revisions to part 807 as described in this document.
5. Could the Electronic Format Requirements Be Waived?
Section 510(p) of the FD&C Act, as amended by FDAAA section 224,
requires the electronic submission of registration and listing
information unless we grant a request for a waiver because the use of
electronic means is not reasonable for the person requesting the
waiver. Consistent with section 510(p), proposed Sec. 807.21(b) would
permit establishments to request waivers from the new electronic
submission requirements.
We do not anticipate many waiver requests because the business
expenses associated with owning a personal computer, obtaining an e-
mail address, and subscribing to Internet access are low. During the
first 3 months of operation of the Web-based system, i.e, October
through December 2007, we received fewer than 10 requests for waivers
from the requirement to submit registration and listing data
electronically. As we received data electronically for more than 16,000
establishments for that same period, the waiver requests amount to less
than one-tenth of 1 percent of the total number of establishments that
have responded.
Under proposed Sec. 807.21(b), we may grant a waiver request upon
a showing that use of the Internet to access our Web-based registration
and listing system is not reasonable for the person requesting the
waiver. This is consistent with the requirement described in section
510(p) of the FD&C Act, as amended by section 224 of FDAAA. Under
proposed Sec. 807.21(b), the waiver request must explain why use of
the Internet and our electronic registration and listing system is not
reasonable for the requestor and must include a telephone number and
mailing address where we can contact the person making the request.
This information is necessary to contact the requestor and for FDA to
determine whether a waiver can be granted. It should be noted, however,
that waiver requests stating that it is not possible for the owner or
operator to own a computer will probably not be granted since there are
other ways to access the Internet. For example, most public libraries
have computers with Internet access that can be used, often free of
charge, by members of the public.
In those instances when we do grant a request for a waiver, we plan
to provide information at that time regarding how the requestor should
submit its registration and listing information.
E. Miscellaneous
1. What Are the Proposed Requirements for an Official Correspondent and
a U.S. Agent?
Under proposed Sec. 807.25(e) owners or operators that are subject
to the registration requirements in proposed part 807 would continue to
have to designate an official correspondent for each establishment. The
official correspondent would be responsible for:
Entering and updating all registration and listing
information for the establishment in the electronic system or, if the
owner or operator has been granted a waiver from using the electronic
system, providing all registration and listing information for the
establishment to FDA via postal mail;
Serving as the point of contact with FDA on matters
relating to the annual registration of the establishment and all
updates of registration information;
Serving as the point of contact with FDA on matters
relating to initial device listings and device listing updates,
including discontinuances;
Maintaining a current list of officers and directors for
submission to FDA upon FDA's request; and
The receipt of pertinent correspondence from FDA directed
to and involving the owner or operator and/or any of the owner or
operator's establishments. Under proposed Sec. 807.25(e), we are also
adding the requirement that each owner or operator provide FDA with the
name of a contact person at the owner or operator's offices who will be
responsible for identifying the official correspondent for each
establishment. The owner or operator contact person will be the
official correspondent in the event no one else has been properly
designated. The contact person would be responsible for establishing
and updating the owner or operator's electronic registration and
[[Page 14523]]
listing accounts and all subaccounts that may be necessary.
In addition, each foreign establishment is required under our
existing regulations at Sec. 807.40(b) to designate a single U.S.
agent. This proposal retains that requirement. The U.S. agent's
responsibilities include:
Helping FDA communicate with the foreign establishment;
Responding to questions concerning the foreign
establishment's devices; and
Helping us schedule inspections.
We would not object if the same individual serves as both the U.S.
agent and the official correspondent for a foreign establishment, or if
the same individual serves as the U.S. agent for more than one foreign
establishment.
We are not proposing to change the requirement that each foreign
establishment be limited to designating only one U.S. agent. We
interpret section 510(i) of the FD&C Act as allowing only one U.S.
agent for each foreign establishment because section 510(i) refers to
the U.S. agent in singular, rather than plural, terms. We also
interpret section 510(i) of the FD&C Act as requiring that the U.S.
agent must be located in the United States. These provisions are also
consistent with the use of ``U.S. agent'' in the agency's interim final
rule entitled ``Registration of Food Facilities Under the Public Health
Security and Bioterrorism Preparedness Act of 2002'' (68 FR 58894 at
58915, October 10, 2003).
Currently, the provisions concerning a U.S. agent are set forth in
our regulations at Sec. Sec. 807.3(r) and 807.40(b). Current Sec.
807.3(r) defines U.S. agent as a person residing or maintaining a place
of business in the United States whom a foreign establishment
designates as its agent. The definition further states that the term
``United States agent'' excludes mailboxes, answering machines or
services, or other places where an individual acting as the foreign
establishment's agent is not physically present. Section 807.40(b) also
indicates that the U.S. agent must reside or maintain a place of
business in the United States, and adds that if FDA is unable to
contact the foreign establishment directly or expeditiously, FDA may
provide information to the U.S. agent and this action will be
considered as equivalent to giving the same information to the foreign
establishment itself.
This proposal would retain the requirements from the existing
regulations concerning the U.S. agent.
2. What Legal Status Is Conferred by Registration and Listing?
This proposal would retain provisions in our existing regulations,
at Sec. Sec. 807.35(c) and 807.39, addressing the legal status of
registrants and their devices. These provisions indicate that
registration of an establishment or listing of a device does not denote
approval of the establishment, the device, or other devices of the
establishment; nor does it mean that a product may be legally marketed.
Any representation that creates an impression of official approval or
that a device is approved or is legally marketable because of
registration or listing would be misleading and would constitute
misbranding under section 502 of the FD&C Act (21 U.S.C. 352).
3. Would the Proposal Require Electronic Submission of Labeling and
Advertisements?
Current Sec. 807.31(e) requires owners or operators to submit
labeling and in certain cases advertisements or other information for
their device when they are specifically requested to do so by FDA.
Currently such information, if requested, would be provided to us in
paper format. This proposal would give owners or operators from whom
copies of labeling or advertisements are requested under Sec. 807.31
(which we are proposing to redesignate as Sec. 807.26) the option of
submitting the information to us either in paper format or
electronically. In those instances where the owner or operator chooses
to submit the requested information electronically, they would do so by
email rather than using FURLs. We intend to indicate in public Docket
No. 92S-0251 that we are prepared to accept this information in
electronic format.
4. What Registration and Listing Information Would Be Made Available
for Public Disclosure?
Current Sec. 807.37 pertains to the public availability of
registration and listing information. The proposal would revoke the
introductory text of current Sec. 807.37(a), which includes a
description of the types of forms available for inspection, the
addresses at which such forms can be inspected, and the addresses to
which requests for verification of registration numbers and requests
for locations of registered establishments can be directed. We are
proposing to revoke this introductory text because these forms are no
longer being used under FURLS. Instead, we intend to continue the
current practice of making registration and listing information that is
available for public disclosure accessible from our Web site. We expect
that the registration and listing information available on the Web
under the new electronic system will not change from that which is
currently available. This initiative is consistent with the GPEA and
also helps to reduce the number of Freedom of Information Act (5 U.S.C.
552) requests we receive for registration and listing information.
5. How Would Part 11 Apply to the Electronic Submission of Registration
and Listing Information?
Under part 807 as revised by this proposal, the submission of
registration and listing information would be subject to the
requirements of part 11 (21 CFR part 11), except for the requirements
under Sec. 11.10(b), (c), and (e) and the corresponding requirements
under Sec. 11.30.
In the Federal Register of March 20, 1997 (62 FR 13430), we
published regulations on electronic records and electronic signatures
(part 11). Part 11 regulations, among other things, set forth the
criteria under which records submitted to us may be submitted in
electronic format in lieu of paper records. Section 11.2(b) provides
for the submission of electronic records instead of paper records
provided the requirements of Part 11 are met and the documents or parts
of documents to be submitted have been identified by us in public
Docket No. 92S-0251 as being the type of submission we are prepared to
accept in electronic format.
Part 11 permits the widest possible use of electronic technology,
compatible with our responsibility to promote and protect the public
health (62 FR 13430). Part 11 helps to ensure the authenticity,
integrity, and, when appropriate, the confidentiality of electronic
records. Part 11 also helps to safeguard against the possible
repudiation of those records. The controls in subpart B of part 11 are
intended to further this purpose.
In the Federal Register of September 5, 2003 (68 FR 52779), we
announced the availability of a guidance for industry entitled ``Part
11, Electronic Records; Electronic Signatures--Scope and Application''
(the part 11 guidance). The part 11 guidance explains our current
thinking regarding the requirements and application of part 11 and
states that we intend to exercise enforcement discretion in the manner
specified in the guidance with respect to the validation (Sec. 11.10
(a)), audit trail (Sec. 11.10(e) and (k)(2)), record retention (Sec.
11.10(c)), and copies of records (Sec. 11.10(b)) requirements of part
11, and any corresponding requirements in Sec. 11.30. In addition, we
announced that
[[Page 14524]]
we intend to exercise enforcement discretion and do not intend to take
(or recommend) action to enforce any part 11 requirements with regard
to systems that were operational before August 20, 1997, the effective
date of part 11 (commonly known as legacy systems) under the
circumstances described in section III.C.3 of the part 11 guidance. The
part 11 requirements from which we propose exemptions in this proposal
differ from the part 11 requirements for which we intend to exercise
enforcement discretion, as described in the part 11 guidance. They
differ because the proposed exemptions in this rule are specific to the
electronic submission of registration and listing information for
devices that would be covered under proposed part 807, whereas the part
11 guidance applies to the maintenance of all electronic records and to
all electronic submissions subject to part 11.
With respect to the electronic submission of registration and
listing information, as previously noted, we believe, as provided in
proposed Sec. 807.25(a), that several of the requirements in subpart B
of part 11 are not necessary to further the goals of part 11. Because
we control the electronic device registration and listing system
(FURLS), certain controls for systems would not apply to the submission
of registration and listing information, such as:
The ability to generate accurate and complete copies of
records in both human readable and electronic form suitable for
inspection, review, and copying by the agency (Sec. 11.10(b));
The protection of records to enable their accurate and
ready retrieval throughout the records retention period (Sec.
11.10(c));
The use of secure, computer-generated, time-stamped audit
trails to independently record the date and time of operator entries
and actions that create, modify, or delete electronic records (Sec.
11.10(e)); and
The corresponding controls of Sec. 11.30.
You would be exempt from these subpart B controls because FURLS is
designed to ensure the authenticity, integrity, and confidentiality of
this information in several ways. For example, we would control the
database, and you would only be able to enter and/or revise information
in your own account. In addition, the database would contain records of
registration and listing information, including the history of all
changes to those records, and we could generate accurate and complete
copies of these records.
With respect to the electronic submission of labeling or
advertisements in connection with device listing, we believe, as
provided in proposed Sec. 807.26, that the following requirements in
subpart B of part 11 are not necessary to further the goals of part 11:
The validation of systems to ensure accuracy, reliability,
consistent intended performance, and the ability to discern invalid or
altered records (Sec. 11.10(a));
The protection of records to enable their accurate and
ready retrieval throughout the records retention period (Sec.
11.10(c));
Limiting system access to authorized individuals (Sec.
11.10(d));
The use of secure, computer-generated, time-stamped audit
trails to independently record the date and time of operator entries
and actions that create, modify, or delete electronic records (Sec.
11.10(e));
The use of operational system checks to enforce permitted
sequencing of steps and events, as appropriate (Sec. 11.10(f));
The use of authority checks to ensure that only authorized
individuals can use the system, electronically sign a record, access
the operation or computer system input or output device, alter a
record, or perform the operation at hand (Sec. 11.10(g));
The use of device checks to determine, as appropriate, the
validity of the source of data input or operational instruction (Sec.
11.10(h));
The use of appropriate controls over certain systems
documentation (Sec. 11.10(k)); and
The corresponding controls of Sec. 11.30.
We are proposing to exempt the electronic submission of labeling
and advertisements from these controls for systems because we believe
these requirements are not critical to ensure the quality of the
labeling and advertisements that would be submitted under this proposed
rule and we do not think it is necessary for industry to expend
resources on controls that are not necessary to further the goals of
part 11.
With regard to labeling and advertising submissions in electronic
format, we recognize there are some differences with respect to the
exemptions from part 11 requirements provided in this proposed rule
(that is, Sec. 11.10(a), (c) through (h), and (k), and the
corresponding requirements of Sec. 11.30), and the part 11
requirements set forth in the part 11 guidance for which we intend to
exercise enforcement discretion (that is, Sec. 11.10(a) through (c),
(e), and (k)(2), and the corresponding requirements in Sec. 11.30).
Although this proposal does not provide an exemption from Sec.
11.10(b) for the labeling and advertisements, the part 11 guidance
announces that we intend to exercise enforcement discretion with
respect to that section in the manner described in the guidance.
If this proposed rule is finalized, we intend to identify in public
Docket No. 92S-0251 the registration and listing information and the
labeling and advertising information specified previously as types of
records that we are prepared to accept in electronic format.
F. Conforming Actions
The proposed changes will not result in changes to any regulations
other than part 807.
V. Legal Authority
We have the legal authority to amend our regulations on foreign and
domestic establishment registration and listing for human devices. The
statutory basis for our authority includes sections 201, 301, 501, 502,
510, 513, 515, 519-520, 701, 704, 801, and 903 of the FD&C Act (21
U.S.C. 321, 331, 351, 352, 360c, 360e, 360i-360j, 371, 374, 381, and
393); and sections 361 and 368 of the Public Health Service Act (42
U.S.C. 264 and 271) (the PHS Act).
Section 510(c) of the FD&C Act requires every person upon first
engaging in the manufacture, preparation, propagation, compounding, or
processing of a device to immediately register with the Secretary his
name, place of business, and the establishment. The provisions in
section 510(b) and (d) of the FD&C Act require annual registration and
registration of additional establishments, respectively. As amended by
section 222 of FDAAA, section 510(b) of the FD&C Act requires that
annual registration take place during the period beginning on October 1
and ending on December 31 of each year. Section 510(i) of the FD&C Act,
as amended by section 222 of FDAAA, requires any establishment within
any foreign country engaged in the manufacture, preparation,
propagation, compounding, or processing of a device that is imported or
offered for import into the United States, upon first engaging in such
activity, to immediately register with the Secretary through electronic
means, and thereafter to register annually during the period beginning
on October 1 and ending on December 31 of each year. These provisions,
together with section 701(a) (among others) of the FD&C Act,
[[Page 14525]]
authorize us to require the submission of the registration information
specified in the proposal. The information specified in this proposal
would help us identify who is manufacturing, repacking, or relabeling
devices and where those operations are being performed. In addition,
some information (e.g., official correspondent information) would help
us communicate with establishments more effectively and schedule
inspections more efficiently.
Section 510(j)(1) of the act requires every person who registers to
file with the Secretary, at the time of registration, a list of all
devices that are being manufactured, prepared, propagated, compounded,
or processed by the registrant for commercial distribution. That list
must be prepared in the form and manner prescribed by the Secretary and
must be accompanied by a copy of labeling (or the label and package
insert) and, in some cases, advertising, when requested. Section
510(j)(2) of the FD&C Act, as amended by section 223 of FDAAA, requires
each person who registers with the Secretary under this section to
report listing information updates once each year during the period
beginning on October 1 and ending on December 31 of each year. Listing
information gives us a current inventory of marketed devices. These
provisions and others of the FD&C Act, together with section 701(a) of
the FD&C Act, provide authority for requiring the submission of the
listing information set forth in this proposal. The device listing
information specified in this proposal would help us: (1) Develop a
more current, robust inventory of devices as a counter-terrorism
measure; (2) administer our postmarket surveillance programs more
effectively; (3) facilitate recalls of products; (4) identify devices
in short supply in the event of a national emergency; and (5) identify
devices marketed in violation of the FD&C Act.
Section 510(p) of the FD&C Act, as amended by section 224 of FDAAA,
requires that registration and listing information be submitted
electronically, subject to FDA's grant of waivers to individual
requestors who meet the criteria set forth in section 510(p).
Electronic receipt of registration and listing information will enable
us to shift resources from performing more ministerial tasks, such as
data entry, to pursuing important public health objectives such as
those described in section I of this document. Electronic receipt of
registration and listing information also will help us with the
efficient enforcement of the act because we would be able to
distinguish situations where there has been noncompliance with
registration and listing requirements from situations where there have
been no changes in information. The failure to register or list is a
prohibited act under section 301(p) of the FD&C Act and the failure to
do either renders a device misbranded under section 502(o) of the FD&C
Act.
VI. Analysis of Economic Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Office of Management
and Budget has determined that this proposed rule is a significant
regulatory action as defined by the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the burdens imposed by this proposed rule
are expected to be minor, the agency proposes to certify that the final
rule will not have a significant economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $130 million, using the most current (2007) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
We contracted with the Eastern Research Group, Inc. (ERG), to
collect data, interview industry experts, and estimate the costs and
benefits of the proposed rule. The analysis in support of the effects
of the proposed rule (ERG Memo) is on file with the Division of Dockets
Management. ERG identified several very small impacts, both costs and
benefits, associated with this proposed rule. For most of these
impacts, ERG found the incremental costs and savings to be so small
that it was not a meaningful exercise to generate numeric estimates.\1\
ERG was able identify recurring costs associated with this proposed
rule, plus additional costs that would not apply to U.S.
establishments. After updating ERG's findings with more recent cost
information, we find annual costs of $340,000 associated with this
proposed rule, and an additional $138,000 that would only affect non-
U.S. establishments. We were unable to quantify specific benefits
attributable to the proposed rule. However, we believe the ultimate use
of electronic registration and listing data, the mandate under the
Bioterrorism Act to collect additional pieces of registration data, and
the requirement under the Bioterrorism Act and FDAAA that information
be submitted to FDA electronically justify taking this action.
---------------------------------------------------------------------------
\1\ ERG memorandum from Cal Franz, et al., September 15, 2008,
(hereinafter referred to as ERG Memo), p. 1.
---------------------------------------------------------------------------
A. The Need for Regulation
As discussed elsewhere in this preamble, section 224 of FDAAA
amended section 510(p) of the FD&C Act to require establishment
registrations and device listings to be submitted to FDA by electronic
means unless the Secretary grants a waiver from electronic submission
requirements. We currently maintain databases that contain
establishment registration and device listing information obtained from
owners and operators of device establishments. Prior to FDAAA, these
databases relied on paper forms submitted by the owners and operators
to us, which were then forwarded by us to a data entry contractor for
input into our device registration and listing databases.
Our device registration and listing databases play an important
role in our efforts to accomplish many regulatory and statutory
objectives. For example, we can use this information to identify device
manufacturers to facilitate recalls or information alerts in the case
of potential safety concerns. We also use it to plan and conduct
inspections, administer postmarket surveillance, generate estimates of
the number of businesses that are affected by our rulemaking, and to
otherwise exercise competent oversight of the device industry.
The quality and completeness of these databases depends on prompt
submission of information and the
[[Page 14526]]
immediate inclusion of the data in our system. Under a paper-based
registration and listing system, we were unable to readily verify the
accuracy of the information submitted and, in some instances,
manufacturers were not timely in informing us of changes. In addition,
because we were using physical paper forms, it was possible for
information to be mishandled or lost before being added to the system,
thereby further reducing the reliability of the databases.
In accordance with FDAAA, the agency began collecting registration
and listing information using FURLS, FDA's new Internet-based
electronic registration and listing system which became operational on
October 1, 2007. The electronic submission of information makes the
registration and listing process more efficient for industry and allows
us to review and use such information more quickly, thus helping to
ensure that medical devices will be safe and effective.
Despite the obvious public health advantages to society of using an
electronic device registration and listing system, the private returns
alone would not be adequate to move the entire device industry to a new
registration and listing format that would meet the requirements of
section 510(i) and (p) of the FD&C Act. Because the social benefits are
largely external to the firms, the large number of entities operating
individually cannot be expected to voluntarily move to a new uniform
standard. Few entities would choose to adopt a new format without
significant private benefits.
B. Background
ERG examined FDA's databases of registered device establishments
and listed devices and estimates that revisions to the existing device
registration and listing regulations would affect approximately 29,370
owner-operators of approximately 33,500 registered device
establishments, and 89,200 listed devices. Of the roughly 33,500
registered establishments, approximately 19,700 are registered as
domestic and 13,800 are registered as foreign.\2\
---------------------------------------------------------------------------
\2\ See ERG , appendix B, table 1.
---------------------------------------------------------------------------
Under the existing regulations, with certain exceptions, owners or
operators of establishments that engage in the manufacture,
preparation, propagation, compounding, assembly, or processing of a
device intended for human use must, in addition to other requirements,
register their establishments and submit listing information for each
of their devices in commercial distribution. Foreign device
establishments engaged in the manufacture, preparation, propagation,
compounding, or processing of a device that is imported or offered for
import into the United States must comply with the registration and
listing requirements, including the requirement to identify a U.S.
agent. Until the recent change to electronic submissions mandated by
section 224 of FDAAA, all domestic and foreign registration and listing
information was submitted using paper forms.
C. The Proposed Regulation
A major objective of this proposal is to update FDA's regulations
at part 807 to reflect the requirement for electronic submission of
establishment registration and device listing information as required
by FDAAA. A paper-based system of registering and listing is
burdensome. It does not facilitate timely updates, which does not allow
for the best use of these data in inspections and recalls. We believe
that electronic submission of registration and listing information
improves the quality and timeliness of information available to FDA. In
addition, a system of electronic registration and listing improves the
quality and timeliness of information available to health care
professionals and consumers. Furthermore, to the extent that these
quality improvements to the registration and listing process facilitate
device recalls, complement postmarketing surveillance programs, help
ensure the safety of imported devices, improve the scheduling and
planning of inspections, and otherwise assist the agency in carrying
out its statutory and regulatory objectives, there is a broad public
health benefit. Moreover, the development and maintenance of high
quality databases of information about devices and device
establishments would enhance future uses of technology in the delivery
of health care. An electronic database that contains current and
accurate information about devices could, for example, facilitate the
development of technology that would allow for communication among
devices, giving them additional functionality and the potential for
interoperability.
This proposed regulation would also slightly modify the types of
information that would need to be submitted as registration and listing
information. However, these modifications would be minor and are
generally consistent with achieving a more accurate and useful database
of device industry information.
D. Estimated Impacts
ERG reviewed the proposed registration and listing regulation,
comparing it to the current provisions, and projected the impacts of
the proposed regulation. A memorandum prepared by ERG based on this
review identifies eight areas where revisions to the current device
registration and listing provisions may affect the cost of
compliance.\3\ These impacts would stem from provisions associated
with:
---------------------------------------------------------------------------
\3\ ERG memo, p. 3.
---------------------------------------------------------------------------
The creation of an account on FURLS;
The requirement for submission of additional information
as part of the annual registration process;
Modifications to requirements relating to registration
information updates;
The requirement for submission of additional information
when listing a device;
Changes relating to the requirement for semiannual review
and update of device listing information;
The waiver from the requirement to register and list by
electronic means;
The proposed elimination of the exemptions from
registration and listing requirements for foreign establishments whose
devices enter a foreign trade zone and are re-exported from the foreign
trade zone without having entered U.S. commerce and the exemption for
devices that are imported under section 801(d)(3) of the FD&C Act
(import-for-export provision); and
The proposed elimination of the exemption from
registration and listing requirements for contract manufacturers and
contract sterilizers who do not commercially distribute the devices.
Because most of the identified regulatory impacts only slightly
increase or decrease the costs of registering and listing, sometimes
involving offsetting impacts, we present the impacts grouped by the
eight impact areas identified previously, as opposed to trying to
present the impacts as distinct groups of costs and benefits.
1. Creation of FURLS Accounts
Under the proposed rule, establishments would go through the one-
time process of creating a FURLS account. According to ERG, the costs
associated with setting up the FURLS account are negligible.\4\
---------------------------------------------------------------------------
\4\ ERG memo, p. 5
---------------------------------------------------------------------------
2. Changes to Annual Registration Information
This proposed rule could affect the burden on establishments by
changing the information they submit in the annual registration
process. ERG found that differences in the information collected
currently and under the
[[Page 14527]]
proposed rule would be minor and should not increase the time spent
completing the registration.\5\ Some of the additional information is
already submitted voluntarily. For example, the e-mail addresses for
the establishment's official correspondent and owner-operator, as well
as the universal resource locator (URL) for the establishment's Web
site, are already being collected. There would be little, if any
additional burden for those establishments not currently providing this
information. There would be modest savings associated with the annual
registration process, as establishments would be able to access and
edit registration information online and would no longer have to wait
for physical forms to be mailed from FDA, review them, make edits, and
mail the forms back to FDA.
---------------------------------------------------------------------------
\5\ ERG memo, p. 6.
---------------------------------------------------------------------------
As amended by section 321 of the Bioterrorism Act, section 510(i)
of the FD&C Act requires foreign establishments whose devices are
imported or offered for import to the United States to identify and
provide contact information for importers of the establishment's device
that are known to the establishment and also those persons who import
or offer for import the device into the United States. According to the
ERG memo, foreign establishments identifying importers known to them
and persons who import or offer for import the establishments' devices
would typically be identifying one or two entities of each type with
readily available contact information, so the impact would be
negligible.\6\ OMB Circular A-4 directs us to carefully evaluate new
U.S. rules that might act as non-tariff barriers to imported goods. As
the burden to these foreign establishments would be quite small and
would not have a significant adverse effect on trade, the impact on
U.S. consumers from this provision would be negligible.
---------------------------------------------------------------------------
\6\ ERG memo, p. 5.
---------------------------------------------------------------------------
3. Changes Relating to the Requirement to Update Registration
Information
Under proposed Sec. 807.22(b)(2), establishments would be required
to update their registration within 30 days if their registration
information were to change. Current Sec. 807.26 requires that
establishments update registration information for a change in
ownership or a change in the location of the establishment. As the
proposed rule includes a broader set of circumstances requiring a
mandatory update, it has the potential to be slightly more burdensome.
Under the proposed rule, however, establishments would provide updates
electronically, as opposed to submitting such information to FDA using
a paper form as required by current Sec. 807.26. ERG found that the
ability to submit updated information through FURLS rather than
completing and mailing paper forms would result in a net reduction in
administrative burden and, therefore, a cost savings to establishments.
ERG did not quantify the amount of the estimated savings, but we feel
it would roughly negate any increase in burden from the increased
likelihood of a mandatory update.
4. Requirement for Additional Device Listing Information
Under proposed Sec. 807.25, establishments would be required to
submit additional information, including 510(k) numbers and HDE numbers
among the types of premarket submission numbers submitted to FDA for
non-exempt devices. Establishments would also submit all proprietary
and brand names under which each device is marketed. Although the
agency already collects proprietary or brand names as part of device
listings, the device listing form specified for use under the existing
regulation has a single block of 80 characters for proprietary and
brand names, which may have been restricting the amount of information
establishments have been providing. In contrast, establishments using
FURLS to list their devices have an unlimited amount of space within
which to provide information and therefore could submit more data.
According to the ERG memo, device listings would rarely have more than
three proprietary or brand names, so the additional information that
establishments would be providing under the proposed rule would be
limited.\7\
---------------------------------------------------------------------------
\7\ ERG memo, p. 5.
---------------------------------------------------------------------------
Under proposed Sec. 807.25(g)(4), establishments also would be
required to submit 510(k) and HDE numbers for non-exempt devices as
part of the listing process. This information has been collected by FDA
on a voluntary basis since 2005. It is our experience from processing
these forms that most establishments submitting device listings since
this practice began in 2005 already provide 510(k) and HDE numbers.
Because these establishments already are complying with the proposal,
they would not face an additional burden as a result of this new
requirement. However, there was an additional burden associated with
providing 510(k) and HDE numbers for those devices listed prior to
2005. Because we have already begun to collect information on these
devices electronically, much of this one-time burden has already been
incurred. Based on a query of non-exempt listings included in FDA's
registration and listing database, FDA estimated that 9,300 owners or
operators would provide submission numbers for approximately 31,000
device listings. We believe that affected owners or operators needed
only a few minutes to look up this information from readily available
sources.\8\ ERG did not attempt to quantify this very small burden, but
noted that the inclusion of the 510(k) number in the device listing
would result in significant benefits. Such information would improve
our postmarket surveillance efforts by permitting devices to be tracked
based on the submission number assigned to the particular device, as
opposed to the previous method of tracking based on the reported
product codes which did not necessarily correspond to the product codes
under which a device was cleared. Also, having the registrant supply
the premarket submission number and FDA determine the appropriate
product code saves time, as incorrect product codes can lead to delays
in listing.
---------------------------------------------------------------------------
\8\ ERG memo, p. 6.
---------------------------------------------------------------------------
5. Changes Relating to Review and Update of Device Listings
Section 510(j)(2) of the FD&C Act, as amended by section 223 of
FDAAA, now requires device listings to be updated once each year during
the period beginning on October 1 and ending on December 31.
Previously, as reflected in the current registration and listing
regulations, registrants had to review and update their device listings
on a semiannual basis, during June and December. In the past, FDA has
not strictly enforced this requirement but has encouraged
establishments to update their listings throughout the year whenever
information has changed. Thus, although the required updates would be
less frequent and less burdensome, we recognize the potential for a
minor impact associated with increased enforcement of an existing
requirement. We believe any additional impact would be extremely small,
and we do not attempt to quantify it.
6. Requests for a Waiver from Submitting Information Electronically
Under the proposed rule, parties for whom registering and listing
by electronic means is not reasonable may request a waiver from FDA.
Because one would only need to have access to a
[[Page 14528]]
computer, Internet access, and an e-mail address to register and list
by electronic means, we do not anticipate that we will receive many
requests for waivers.
For the first few months of operation (i.e., October through
December 2007) of the Web-based system, , FDA received fewer than 10
requests for waivers from the requirement to submit registration and
listing information electronically. As FDA received electronic
submissions for more than 16,000 establishments over that period, these
requests amount to about 0.06 percent of the total number of
establishments that responded.
Based on information taken from our databases as of October 2007,
FDA estimated there were 29,370 owners or operators who collectively
registered a total of 33,490 device establishments. If 0.06 percent of
the 33,490 total device establishments would request waivers from FDA,
there would be 20 requests (33,490 x 0.0006). We estimate that the
annual burden on these establishments would be an hour of time from a
mid-level manager to draft, approve, and mail a letter. Assuming a
burden of 20 hours and a labor cost of $41 per hour including benefits,
the cost for all affected establishments would be $820 ($41 per hour x
20 hours).\9\ This estimate may overstate the actual burden, as we
received only nine waiver requests in 2008.
---------------------------------------------------------------------------
\9\ We use a mean wage rate of $31.55 for compliance officers in
the medical equipment and supplies manufacturing industry and add 30
percent for benefits.
---------------------------------------------------------------------------
We anticipate a small number of additional firms would enter the
device industry over the next several years and would need to list and
register. To the extent that a small fraction of these firms would
request waivers, there may be small additional costs in the future.
7. Elimination of Exemptions for Some Foreign Establishments
Under current Sec. 807.40(a), foreign establishments are not
required to comply with the registration and listing requirements if
their device enters a foreign trade zone and is re-exported from that
foreign trade zone without having entered U.S. commerce. As previously
discussed, the proposed rule would eliminate the exemption from
registration and listing requirements for such establishments.
Current Sec. 807.40(c), which states that no device may be
imported or offered for import into the United States unless the device
is listed and is manufactured, prepared, propagated, compounded, or
processed at a registered foreign establishment, also states that this
restriction does not apply to a device imported under section 801(d)(3)
of the FD&C Act (``import-for-export'' provision). As previously
discussed, we are proposing to eliminate the exemption from
registration and listing requirements for devices imported under
section 801(d)(3). This means such devices would have to be listed and
the foreign establishments that manufacture these devices would have to
register with FDA. ERG estimates that the burden of listing would be
2.5 hours per affected device. Assuming an hourly labor cost of $41 per
hour, the cost of this provision to foreign establishments would be
$103 per device.
ERG has reviewed the databases maintained by FDA's Division of
Import Operations and Policy and found that 1,344 shipments of devices
entered the United States under the ``import-for-export'' provision in
2006.\10\ This figure represents approximately 0.13 percent of the
device shipments to the United States. If each of these shipments
required establishment registration and device listing, the cost to
foreign exporters would be less than $138,000 (1,344 shipments x 2.5
hours per shipment x $41/hour). These are one-time costs, as subsequent
shipments of the same device would not require an additional
registration and listing. ERG concludes foreign establishments may
incur future costs if there are shipments of devices not previously
listed and assumes the estimated first year cost is incurred annually.
We believe future annual costs would be substantially less than
$138,000 but we do not attempt to quantify them.
---------------------------------------------------------------------------
\10\ ERG memo, p. 10.
---------------------------------------------------------------------------
ERG was unable to obtain information on the number of devices and
firms affected by the loss of the exemption for devices imported into
foreign trade zones. We believe the impact of this loss of exemption on
individual foreign firms would be very small, but welcome comment on
this issue.
Domestic device establishments would not face a substantial burden
as a result of the elimination of these exemptions. As these devices
are not intended for U.S. commerce, there would be no impact on the
domestic market for these devices. Moreover, based on the small cost
per affected device, we believe the elimination of these exemptions
would have a negligible impact on U.S. industries doing ``import-for-
export'' and operating in foreign trade zones.
For this analysis, we assume that the foreign establishments that
would be losing these exemptions are foreign entities and not merely a
foreign presence of a domestic entity. We lack detailed information on
these establishments and welcome comment on this issue.
8. Elimination of Registration and Listing Exemptions for Contract
Manufacturers and Sterilizers Who Do Not Commercially Distribute the
Devices
Under current Sec. 807.20(a)(2), (c)(1), and (c)(2), contract
manufacturers and contract sterilizers are exempt from registration and
listing obligations if they make or sterilize a device according to
another person's specifications for commercial distribution by the
person who developed the specifications. This proposed rule would
eliminate the exemption from registration and listing for contract
manufacturers and contract sterilizers who do not commercially
distribute. This means that those contract manufacturers and contract
sterilizers that currently do not register or list would be required to
do so. Moreover, because there are recurring obligations associated
with registration and listing, these firms would bear an additional
annual burden.
According to our registration and listing database, as of October
2007, there were 1,304 registered contract manufacturers who had not
previously listed any products. Of these 1,304 establishments, 736 re-
registered in 2006. We also believe there may be contract manufacturers
not registered that would be registering for the first time because of
the loss of exemption. We do not know the number of contract
manufacturers that would be required to register and list, but for the
purposes of this analysis, we estimate that 736 establishments that
would need to register and initially list products. We invite comment
on this estimate.
Based on the October 2007 estimates, the registration and listing
database contains about 89,200 listed devices and approximately 33,500
registered establishments, or about 2.66 devices per establishment. If
that ratio were to hold for the estimated 736 affected contract
manufacturers, we would expect 1,958 additional device listings under
the proposed rule.
Between 1999 and 2006, there was an average of 306 initial contract
manufacturer registrations each year. We therefore estimate 306
additional contract manufacturers would initially register in 2008 (for
fiscal year 2009) and would also incur costs to list their devices, for
a total of 1,042. At 2.66 devices per establishment, this would
[[Page 14529]]
result in 814 additional listings, for a total of 2,772.\11\
---------------------------------------------------------------------------
\11\ We do not follow the assumption in the ERG memo that half
of these contract manufacturers would not register and pay user
fees.
---------------------------------------------------------------------------
According to our registration information, fewer than 160
establishments perform contract sterilizations only. Of these, 116 do
not list devices. Our registration and listing database includes 533
listings for 114 contract sterilizers, or about 4.68 devices per
establishment. Under the proposed rule, the 116 contract sterilizers
who currently register would also have to list. Assuming these contract
sterilizers would list 4.68 devices per establishment, this would
result in 543 additional listings.
ERG estimates that the process of registration and listing would
require 2.5 hours of time per listed device each year.\12\ At a labor
rate of $41 per hour, including benefits, the cost would be $103 per
device or about $270 per contract manufacturing establishment ($103 per
listing x 2.66 listings) and $480 per contract sterilizing
establishment ($103 per listing x 4.68 listings). Across all affected
contract manufacturers, including those registering for fiscal year
2009, the cost would be a recurring $284,000 ($41 per hour x 2.5 hours
x 2,772 listings). For contract sterilizers, the cost would be $56,000
($41 per hour x 2.5 hours x 543 listings). Thus, the impact on contract
manufacturers and contract sterilizers would be an annual $340,000
($284,000 + $56,000). We recognize that we may not be aware of some
contract sterilizers that have never registered. We believe there are
few if any such firms and do not account for them in our analysis, but
invite comment on this issue.
---------------------------------------------------------------------------
\12\ ERG memo, p. 9.
---------------------------------------------------------------------------
The loss of the exemption for contract manufacturers and
sterilizers who do not commercially distribute the devices will not
only result in social economic costs, but will also result in transfers
associated with the payment of user fees. Contract manufacturers and
sterilizers that are required to register will also be required to pay
user fees. According to section 212 of FDAAA, the Fiscal Year (FY) 2009
establishment registration fee is $1,851. At that rate, we estimate FY
2009 fees of $2.14 million, $1.93 million paid by the 1,042 contract
manufacturers and $215,000 paid by the 116 contract sterilizers.
Table 1 of this document summarizes the projected quantified
impacts of this proposed rule. The total annual costs are $340,000.
Foreign establishments would face an additional annual burden of
$138,000 due to the loss of the exemptions from registration and
listing requirements relating to devices entering a foreign trade zone
that are later re-exported without having entered U.S. commerce and
devices that are imported into the United States under section
801(d)(3) of the FD&C Act. There would also be a transfer of $2.14
million in additional user fees paid by contract manufacturers and
sterilizers.
Table 1.--Projected Impacts of the Proposed Rule
----------------------------------------------------------------------------------------------------------------
No. of Affected
Establishment Category Establishments/Devices Incremental Time Cost per Hour\1\ Total Annual Cost\3\
----------------------------------------------------------------------------------------------------------------
Requests for a Waiver 20 establishments 1 hr $41 $820
from Submitting
Information
Electronically
----------------------------------------------------------------------------------------------------------------
Foreign establishments none\2\ 2.5 hrs $41 $0\2\
shipping to United
States under import-for-
export and to foreign
trade zones
----------------------------------------------------------------------------------------------------------------
Elimination of 2,772 devices, 1,042 2.5 hrs $41 $284,000
Exemptions for Contract establishments
Manufacturers
----------------------------------------------------------------------------------------------------------------
Elimination of 543 devices, 116 2.5 hrs $41 $56,000
Exemptions for Contract establishments
Sterilizers
----------------------------------------------------------------------------------------------------------------
All other negligible -- -- negligible\3\
----------------------------------------------------------------------------------------------------------------
Total 1,178 establishments -- -- $340,000
3,315 devices
----------------------------------------------------------------------------------------------------------------
\1\ Average hourly wage for medical equipment and supplies compliance officer, adjusted for benefits.
\2\ Provision would not be expected to affect U.S. establishments. An estimated 1,344 foreign establishments
would face additional annual costs of $138,000.
\3\ Estimated incremental time costs are offset by incremental time savings.
Table 2.--Economic Transfers Associated with the Proposed Rule
------------------------------------------------------------------------
From To Description Cost per Entity Total Cost
------------------------------------------------------------------------
1,042 U.S. Establishme $1,851 $2.14 million
Contract Gover nt
Manufacturer nment Registrati
s and 116 on Fees
Contract
Sterilizers
------------------------------------------------------------------------
The proposed rule would result in benefits associated with an
electronic registration and listing database that would provide more
up-to-date and complete information. The electronic registration and
listing database system could also support future medical and health
information technology initiatives. The proposed rule would increase
the efficiency of the registration and listing process by eliminating
all or nearly all paper submissions. With registration and listing in
an electronic format, we are able to review the submitted information
more quickly and can contact submitting firms immediately through email
if any additional information is needed. In addition, having a database
of registered establishments and listed devices that is more accurate
and complete can
[[Page 14530]]
increase patient safety. For example, an electronic database that
includes 510(k) clearance numbers and current product codes for devices
would help facilitate timely notification of recalls of certain unsafe
devices and prompt identification of the affected manufacturers.
Although the scope of the proposed rule does not extend beyond
registration and listing, the resulting high-quality, electronic
database would facilitate future uses of technology for the public
benefit. A current electronic database of device information could, for
example, facilitate the development of future devices utilizing
wireless connectivity and the interoperation of such devices with
hospital information systems, or with handheld personal digital
assistant (PDA)-type clients used by health care providers or those
managing hospital inventories.
Additionally, having a paper-based registration and listing system
is inconsistent with section 510(p) of the FD&C Act, as amended by
section 224 of FDAAA, and might deter the medical device industry and
healthcare providers from investing in new initiatives that would make
use of electronic device listing and establishment registration data.
E. Regulatory Flexibility Act
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The impact of this proposed rule is almost entirely
attributable to the requirement that contract manufacturers and
contract sterilizers register and list. We have estimated the impacts
on small entities and find that the costs associated with registering
and listing would not be a significant burden for even the smallest of
contract manufacturers and contract sterilizers. Moreover, failing to
remove this exemption for contract manufacturers and sterilizers would
reduce the benefits potentially realized from this proposed rule. These
benefits would include improving the quality and timeliness of
information, facilitating device recalls, complementing postmarket
surveillance programs, ensuring the safety of imported devices, and
improving the scheduling and planning of inspections. Requiring that
contract manufacturers and sterilizers register and list allows for the
appropriate oversight of these types of facilities. For other elements
of this proposed rule, the costs per entity are very small and we do
not believe that this proposed rule would have a significant economic
impact on a substantial number of small entities.
As described earlier in this preamble, this proposed rule would
revise the agency's regulations at part 807 to make them consistent
with the requirement under FDAAA that the agency shift to an electronic
registration and listing format. The incremental costs to
establishments making this switch to electronic registration and
listing are so small as to be difficult to quantify. Certain elements
of the proposed rule may be burdensome to some entities, but these
incremental burdens are estimated to be extremely small. The cost of
submitting a waiver claiming electronic listing and registration to be
unreasonable would be an estimated $41. The cost of registering and
listing a device because of the loss of the exemptions from
registration and listing requirements for devices imported into foreign
trade zones or imported under section 801(d)(3) of the FD&C Act is not
expected to have an effect on domestic establishments. Other elements
of the proposed rule involve the submission of information not
currently required but readily available and the estimated cost of
compliance would be so small as to be difficult to estimate.
Contract manufacturers and contract sterilizers who do not
commercially distribute the devices they make or sterilize would be
faced with a new requirement to register and list. We do not know how
many of the affected contract manufacturers and contract sterilizers
would be categorized as small. As shown in table 1 of this document, we
estimate 1,042 affected contract manufacturers and 116 affected
contract sterilizers. Our internal databases include some contract
manufacturers and sterilizers that have in the past voluntarily
registered. A review of the contract sterilizers in this database
indicate that many are described in external databases as being part of
NAICS code 339113 (Surgical Appliance and Supplies Manufacturing).
Because of the specific expertise, capital requirements, and economies
of scale associated with contract sterilization, we expect contract
sterilizers would have more employees and more revenues per employee
than would a typical establishment in this class. Medical device
contract manufacturers fit in NAICS code 339112 (Surgical and Medical
Instrument Manufacturing). For both of these industry classifications,
the U.S. Small Business Administration has defined a small business as
one with 500 or fewer employees.\13\
---------------------------------------------------------------------------
\13\ U. S. Small Business Administration, ``Table of Small
Business Size Standards Matched to North American Industry
Classification System Codes,'' August 22, 2008, http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf.
---------------------------------------------------------------------------
According to the U.S. Census, there are 1,352 establishments in
class 339112 with 1,302 of them (96 percent) having fewer than 500
employees.\14\ Census information on class 339113 lists 1,845
establishments, with 1,805 of them (98 percent) having fewer than 500
employees.\15\ Applying these profiles to our estimated contract
manufacturers and contract sterilizers, there would be 1,000 small
affected contract manufacturers (96 percent of 1,042) and 114 small
affected contract sterilizers (98 percent of 118).
---------------------------------------------------------------------------
\14\ U.S. Census Bureau, 2002 Economic Census, ``Surgical and
Medical Instrument Manufacturing: 2002,'' Table 4, p. 4, released
December 2004, http://www.census.gov/prod/ec02/ec0231i339112.pdf.
\15\ U.S. Census Bureau, 2002 Economic Census, ``Surgical
Appliance and Supplies Manufacturing,'' Table 4, p. 4, released
December 2004, http://www.census.gov/prod/ec02/ec0231i339113.pdf.
---------------------------------------------------------------------------
For class 339112 covering contract manufacturers, we consider the
smallest establishment group with one to four employees. There are 388
establishments with a total of 839 employees and a total value of
shipments of approximately $130 million. Average revenue per employee
is approximately $150,000. The average establishment in this group has
2.2 employees and receipts of $331,000. As discussed in section V.I.D
of this document, establishment registration user fees are $1,851 for
FY 2009. As shown in table 1 of this document, the estimated annual
burden of listing a device is 2.5 hours at $41 per hour, or $103. A
small contract manufacturer with a single listed device would face an
annual burden of $1,851 plus $103, or $1,954, which is 0.59 percent of
annual revenues.
Assuming the smallest contract sterilizers have five to nine
employees, that particular group in class 339113 has 320 establishments
with a total of 2,165 employees and a total value of shipments of
approximately $380 million. Revenue per employee is approximately
$175,000. The average establishment has 6.8 employees and receipts of
$1.2 million. Contract sterilizers would face an annual establishment
fee of $1,851 plus a cost of $103 per listed device. A small contract
sterilizer with two listed devices would face an annual burden of
$1,851 plus $2,057, or 0.17 percent of annual revenues.
[[Page 14531]]
A $41 burden associated with a waiver request would be about 0.01
percent of revenues for a small entity with revenues in the hundreds of
thousands of dollars. As discussed earlier in this section and in
section V.I.D of this document, other impacts associated with this
proposed rule are all extremely small. We therefore tentatively
conclude that the proposed rule, if issued, would not have a
significant impact on a substantial number of small entities. We also
believe affected entities currently possess the skills required to
comply with the provisions of this proposed rule. FDA requests comment
on the issue of whether this proposed rule would have a significant
impact on a substantial number of small entities.
FDA considered regulatory alternatives such as not regulating and
not requiring registration and listing by contract manufacturers and
contract sterilizers who do not commercially distribute devices. As
explained earlier in this preamble, the electronic submission of
information is mandated under FDAAA. Section A discusses the need to
regulate in greater detail. The benefits associated with agency
oversight of contract manufacturers and contract sterilizers justify
the estimated costs of requiring that they register and list.
VII. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A
description of these provisions is given below with an estimate of the
annual reporting and recordkeeping burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Implementation of Sections 222, 223, and 224 of the Food and Drug
Amendments Act of 2007 (OMB Control No. 0910-0625)--Revision
FDA is proposing to amend its regulations governing medical device
establishment registration and device listing. The proposed revisions
would modify FDA's current regulations at part 807 to reflect recent
statutory amendments to the device registration and listing provisions
of the FD&C Act. FDAAA, which was enacted on September 27, 2007,
amended section 510 of the FD&C Act by requiring domestic and foreign
device establishments to begin submitting their registration and device
listing information to FDA by electronic means rather than on paper
forms, and also specified the timeframes when establishments are
required to submit such information. In accordance with FDAAA, the
agency launched FDA's Unified Registration and Listing System (FURLS),
an internet-based registration and listing system. FDAAA requires
electronic submission of device registration and listing information
unless FDA grants a waiver request.
In addition, this proposal would facilitate FDA's collection of
additional registration information from foreign establishments as
required by the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (Bioterrorism Act). It also would update
certain provisions in part 807 to improve the quality of registration
and listing information available to FDA. FDA relies on having complete
and accurate registration and listing information in order to
accomplish a number of important public health objectives.
A. Statutory Compliance
To comply with the statutory deadline under the provisions of FDAAA
for medical device establishment registration and device listing by
electronic means, including waiver provisions, FDA initially obtained a
6-month OMB approval of the collection of information requirements
under the emergency processing provisions of the Paperwork Reduction
Act (the PRA), and subsequently obtained a 3-year approval of these
requirements under the same assigned OMB Control No. 0910-0625. With
OMB approval of the collection of information requirements, FDA took
several actions: (1) Developed an electronic form ``Device Registration
and Listing Module,'' Form FDA 3673 and (2) developed and implemented
the guidance entitled ``Guidance for Industry and FDA Staff-
Implementation of Medical Device Establishments Registration and Device
Listing Requirements Established by the Food and Drug Administration
Amendments Act of 2007.'' This guidance among other things explained
the recent changes in the device registration and listing program and
the process (instructions) for using FURLS, an Internet-based
registration and listing system.
B. Transition Process From Paper to Electronic Submission
The information collection requirements for paper submissions were
approved under the assigned OMB control number 0910-0387 with the
associated Forms FDA 2891, 2891a, and 2892. Upon approval of electronic
registration and listing information collection requirements under
FDAAA, FDA: ( 1) Replaced the paper forms FDA 2891, 2891a, and 2892
with the electronic data collection instrument, Form FDA 3673; (2)
revised the collection of information 0910-0387 for paper submissions
to include only nonregistration and listing paperwork requirement,
thereby reducing the annual reporting burden requirements (the
registration and listing requirements under FDAAA were updated as a
revision to the collection 0910-0625); (3) following notice in a June
17, 2007, letter to firms, shut down the manual data entry system on
September 15, 2007, and began using the new electronic system on
October 1, 2007; and (4) sent each firm a letter on October 1, 2007,
providing account and password information for the new system.
Description: In accordance with the collection of information
entitled ``Establishment Registration and Device Listing for
Manufacturers and Initial Importers of Devices,'' medical device
establishment owners and operators will be required to electronically
submit establishment registration and device listing information.
Section 510(c) of the FD&C Act requires owners or operators of
domestic establishments upon first engaging in the ``manufacture,
preparation, propagation, compounding, or processing`` of a device or
devices in those establishments to immediately register their name and
place of business and such establishment. Section 510(a)(1) of the FD&C
Act defines the term ``manufacture, preparation, propagation,
compounding, or processing'' to include ``repackaging or otherwise
changing the container, wrapper, or labeling of any * * *
[[Page 14532]]
device package in furtherance of the distribution of the * * * device
from the original place of manufacture to the person who makes final
delivery or sale to the ultimate consumer or user.''
Section 510(a)(2) of the FD&C Act mandates that the term ``name''
include, among other things, the name of each partner of a partnership,
and the name of each corporate officer and director of a corporation.
An owner or operator of a registered establishment must also
immediately register any additional establishment that he owns or
operates in any State and in which he begins the ``manufacture,
preparation, propagation, compounding, or processing'' of a device
(section 510(d) of the FD&C Act). An owner or operator of any
establishment that engages in these activities must also re-register
its establishment once each year during the period beginning on October
1 and ending on December 31 of each year (section 510(b) of the FD&C
Act, as amended by FDAAA).
Section 510(i) of the FD&C Act contains certain registration
requirements pertaining to foreign establishments (e.g., submission of
the name of each importer of the establishment's device in the United
States that is known to the establishment, submission of the name of
each person who imports or offers for import the establishment's device
to the United States for purposes of importation). Section 510(g) of
the FD&C Act provides for certain exemptions from the registration
requirements. In addition, section 510(p) of the FD&CAct, as amended by
FDAAA, requires the electronic submission of device registration and
listing information unless the Secretary grants a request for a waiver
because use of electronic means is not reasonable for the person
requesting the waiver.
Section 510(j)(1) of the FD&C Act requires that every person who
registers must, at the time of registration, submit a list of all
devices that are being manufactured, prepared, propagated, compounded,
or processed by him or her for commercial distribution which have not
been previously listed by him or her. This information must be
submitted in the form and manner prescribed by the Secretary (section
510(j)(1) of the FD&C Act). Prior to FDAAA, section 510(j)(2) of the
FD&C Act required certain changes in listing information to be reported
every June and December, including any material changes in information
previously submitted under the listing provisions. This information
must now be provided only once each year during the period beginning on
October 1 and ending on December 31.
Section 510(e) of the FD&C Act permits the Secretary to prescribe a
uniform system for the identification of devices intended for human use
and may require that persons who are required to list such devices
under section 510(j) shall list such devices in accordance with such a
system. The disclosure provision in section 510(f) of the FD&C Act
requires the Secretary to make available for inspection any
registration filed under section 510. Section 510(f) also provides that
certain listing information must be exempt from disclosure unless the
Secretary finds that such exemption would be inconsistent with
protection of the public health.
Complete and accurate registration and listing information is
necessary to accomplish a number of statutory and regulatory
objectives, such as: Identification of establishments producing
marketed medical devices, identification of establishments producing a
specific device when that device is in short supply or is needed for
national emergency, facilitation of recalls for devices marketed by
owners and operators of device establishments, identification and
cataloguing of marketed devices, administering postmarketing
surveillance programs for devices; identification of devices marketed
in violation of the law; identification and control of devices imported
into the country from foreign establishments; and scheduling and
planning inspections of registered establishments under section 704 of
the FD&C Act.
The electronic collection of establishment registration and device
listing information from medical device establishment owners and
operators also furthers the purpose of several statutes, including: The
FDAAA, the Bioterrorism Act, MDUFMA, and GPEA.
Description of Respondents: Owners or operators of establishments
that engage in the manufacturing, preparation, propagation,
compounding, or processing of a device or devices must register their
establishments and submit listing information for each of their devices
in commercial distribution. Notwithstanding certain exceptions, foreign
device establishments that manufacture, prepare, propagate, compound,
or process a device that is imported or offered for import into the
United States must also comply with the registration and listing
requirements. The total annual estimated burden imposed by this
collection of information is 103,536 hours annually.
FDA estimates the burden of this collection of information as
follows:
Table 3.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section FDA Form Number No. of Frequency per Total Annual Hours per Total
Respondents Response Responses Response Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.20(a)\3\ 3,673 800 1 800 0.75 600
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.21(a)\3\ 3,673 125 1 125 0.5 63
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.21(b)\2\ ................... 20 1 20 1 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.21(b)\3\ ................... 1 1 1 1 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(a)\3\ 3,673 2,566 1 2,566 0.5 1,283
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(b)(1)\3\ 3,673 29,100 1 29,100 0.75 21,825
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(b)(2)\3\ 3,673 3,000 1 3,000 0.5 1,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(b)(3)\3\ 3,673 24,870 1 24,870 1 24,870
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.26(e)\3\ ................... 100 1 100 1 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 14533]]
807.34(a)\2\ ................... 20 1 20 1 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.34(a)\3\ ................... 1 1 1 1 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.40(b)(2)\3\ 3,673 50 1 50 0.5 25
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.40(b)(3)\3\ 3,673 1,836 1 1,836 0.25 459
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.41(a)\3\ 3,673 11,348 1 11,348 0.5 5,674
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.41(b)\3\ 3,673 11,348 1 11,348 0.5 5,674
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total one time burden 40
---------------------------------------------------------------------------------------------------------------------------------------------
Total recurring burden 62,075
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ One Time Burden
\3\ Recurring Burden
Table 4.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per
21 CFR Section No. of Respondents per Recordkeeper Records Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.25(d)\2\ 33,490 1 33,490 .25 8,373
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.26\2\ 16,524 4 66,096 .5 33,048
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 41,421
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Recurring burden.
The currently approved reporting and recordkeeping burden for
electronic registration and listing under OMB No. 0910-0625 is 71,319.
The estimated reporting and recordkeeping burden for electronic
registration and listing under the proposed rule is 103,536 hours, an
increase of 32,217 hours. This increase is due to an under estimate of
the original burden estimate for 0910-0625 and the incremental increase
of respondents no longer exempt from these requirements.
Burden estimates are based on recent experience with the existing
medical device registration and listing program and the economic
analysis provided by ERG. The changes to the actual data collected are,
with one exception, very minor. We are assuming that it will take
approximately the same amount of time to enter the data online using
FURLS as it does to use the portable document format (PDF)-enabled
forms that had been used for initial establishment registration prior
to FURLS becoming operational in October 2007. Any additional burden
associated with creating and using the Web-based system accounts (as
shown in table 3 of this document under Sec. 807.21(a)) should be
offset by the elimination of the need to re-enter identifying
information concerning the establishment or product every time
registration or listing information is updated, which was the case when
updating such information using the PDF-enabled forms.
The recurring burden for the new data collection under Sec. 807.41
(import-related information provided by foreign companies exporting to
the United States) was estimated based on the ERG memo. This report
stated that foreign establishments would typically be identifying one
or two importers and one or two persons who import or offer for import
with readily available contact information.
The estimates for creation of new user accounts under Sec.
807.21(a) are based on the current number of owners or operators, and
experience in account creation using the existing FURLS for Food
Facility Registration. The estimates for the recurring years assume a
similar increase in the number of new owner or operator numbers as were
created in FY 2006.
The estimate for Sec. 807.25(d) in table 5 of this document
(recordkeeping burden) reflects the requirement that owners or
operators keep a list of officers, directors, and partners for each
establishment. Owners or operators will need to provide this
information only when requested by FDA. However, it is assumed that
some effort will need to be expended to keep such lists current.
The requirements shown in table 5 for proposed Sec. 807.26
(renumbered from Sec. 807.31), have not changed based on this revision
to the registration and listing regulations. They reflect other
recordkeeping requirements for devices listed with FDA, and the
requirement to provide these records when requested by FDA. They are
based on experience FDA has had with the existing regulation.
This proposed rule also refers to previously approved collections
of information found in FDA regulations. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in Sec. 807.35(b) have been
approved under OMB control number 0910-0052. This rule is not going to
impact the burden in 0910-0052 that is already accounted for in that
information collection.
To further clarify and track how the burden and associated changes
for this proposed rule have been accounted for during the transition
process from paper to electronic in which the information is
[[Page 14534]]
currently submitted by electronic means through FURLS, FDA has
developed tables 5 and 6 of this document as follows:
Table 5.--Reporting Requirements
----------------------------------------------------------------------------------------------------------------
21 CFR Section/ Section of the 2007 Amendments/ OMB Control No. 21 CFR Section/ NPRM
OMB Control No. 0910-0625 -------------------------------------------
0910-0387 -------------------------------------------------- Electronic Format
------------------- Electronic Format -------------------------------------------
Paper Format --------------------------------------------------
-------------------
Forms FDA Form FDA 3673
2891,2891a, and Form FDA 3673
2892
----------------------------------------------------------------------------------------------------------------
807.22(a) and 222 807.22(a)
807.40
----------------------------------------------------------------------------------------------------------------
807.22(b) 223 807.22(b)(3)
----------------------------------------------------------------------------------------------------------------
807.22(a) and 224 807.22(b)(1)
807.40
----------------------------------------------------------------------------------------------------------------
807.22(b) 224 807.22(a)
----------------------------------------------------------------------------------------------------------------
Not reported 224 807.21(b)
----------------------------------------------------------------------------------------------------------------
Not reported 224 807.21(c)
----------------------------------------------------------------------------------------------------------------
Table 6.--Recordkeeping Requirements
----------------------------------------------------------------------------------------------------------------
21 CFR Section/ Section of the 2007 Amendments OMB Control No. 21 CFR Section/ NPRM
OMB Control No 0910-0625 -------------------------------------------
0910-0387 -------------------------------------------------- Electronic Format
------------------- Electronic Format -------------------------------------------
Paper Format --------------------------------------------------
-------------------
Forms FDA Form FDA 3673
2891,2891a, and Form FDA 3673
2892
----------------------------------------------------------------------------------------------------------------
Not reported 222 807.25(d)
----------------------------------------------------------------------------------------------------------------
807.31 223 807.26
----------------------------------------------------------------------------------------------------------------
In compliance with the PRA, the agency has submitted the revised
information collection provisions of this proposed rule to OMB for
review. Interested persons are requested to send comments regarding the
information collection to OMB (see DATES and ADDRESSES sections of this
document).
VIII. Environmental Impact
The agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IX. Proposed Effective Date
FDA proposes that any final rule based on this proposal become
effective 90 days after its date of publication in the Federal
Register.
X. Proposed Compliance Dates
The proposed rule does not affect self-executing statutory
responsibilities. Those FDAAA provisions establishing registration and
listing requirements that are self-executing must be complied with in
accordance with the statute and do not depend on this proposed rule
becoming final.
XI. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
have substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
Accordingly, the agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.
XII. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
XIII. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but we are not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.
1. Bureau of Labor Statistics, May 2008, National Industry-
Specific Occupational Employment and Wage Estimates, NAICS 339100--
Medical Equipment and Supplies Manufacturing, Occupation (SOC code):
(131041) http://www.bls.gov/oes/current/naics4_339100.htm.
2. Eastern Research Group memorandum from Cal Franz, Derek
Singer, and John Eyraud to FDA, September 15, 2008.
3. Office of Management and Budget, Circular A-4, Regulatory
Analysis, Washington, DC, 2003, http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf.
List of Subjects in 21 CFR Part 807
Imports, Medical devices, Reporting and Recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner
[[Page 14535]]
of Food and Drugs, it is proposed that 21 CFR part 807 be amended as
follows:
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
1. The authority citation for 21 CFR part 807 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.
2. Amend Sec. 807.3 by:
a. Adding ``and'' at the end of paragraph (e)(3);
b. Removing ``;and'' at the end of paragraph (e)(4) and adding a
period in its place;
c. Removing paragraph (e)(5);
d. Revising paragraph (i);
e. Redesignating paragraphs (k) through (s) as paragraphs (l)
through (t), respectively; and
f. Adding a new paragraph (k) and adding paragraphs (u) through
(y).
The revisions and additions read as follows:
Sec. 807.3 Definitions.
* * * * *
(i) Restricted device means a device for which a requirement
restricting sale, distribution, or use has been established by a
regulation issued under section 520(e) of the act, by order as a
condition of premarket approval under section 515(d)(1)(B)(ii) of the
act, or by a performance standard issued in accordance with sections
514(a)(2)(B)(v) and 514(b) of the act.
* * * * *
(k) Product code means the code used by FDA to identify the generic
category of a device.
* * * * *
(u) Fiscal year means the FDA fiscal year, which runs from October
1 through September 30.
(v) FURLS means the Food and Drug Administration's Unified
Registration and Listing System,
(w) FDA premarket submission number means the number assigned by
FDA to a premarket device submission, such as a Premarket Approval
Application (PMA); Investigational Device Exemption (IDE); Humanitarian
Device Exemption (HDE); Investigational New Drug Application (IND); New
Drug Application (NDA); or Premarket Notification (510(k)).
(x) Importer means, for purposes of this part, a company or
individual in the United States that is an owner, consignee, or
recipient, even if not the initial owner, consignee, or recipient, of
the foreign establishment's device that is imported into the United
States. An importer does not include the consumer or patient who
ultimately purchases, receives, or uses the device, unless the foreign
establishment ships the device directly to the consumer or patient.
(y) Person who imports or offers for import means, for purposes of
this part, an agent, broker, or other entity, other than a carrier,
that the foreign establishment uses to facilitate the import of its
device into the United States.
3. Revise Sec. 807.20 to read as follows:
Sec. 807.20 Who must register and submit a device list?
(a) An owner or operator of an establishment not exempt under
section 510(g) of the act or subpart D of this part who is engaged in
the manufacture, preparation, propagation, compounding, assembly, or
processing of a device intended for human use shall register and submit
listing information for those devices in commercial distribution,
except that registration and listing information may be submitted by
the parent, subsidiary, or affiliate company for all the domestic or
foreign establishments under the control of one of these organizations
when operations are conducted at more than one establishment and there
exists joint ownership and control among all the establishments. The
term ``device'' includes all in vitro diagnostic products and in vitro
diagnostic biological products not subject to licensing under section
351 of the Public Health Service Act. An owner or operator of an
establishment located in any State as defined in section 201(a)(1) of
the act shall register its name, places of business, and all
establishments and list the devices whether or not the output of the
establishments or any particular device so listed enters interstate
commerce. The registration and listing requirements shall pertain to
any person who:
(1) Initiates or develops specifications for a device that is to be
manufactured by a second party;
(2) Manufactures a device, including an establishment that
sterilizes or otherwise makes a device for or on behalf of a
specifications developer or any other person;
(3) Repackages or relabels a device;
(4) Reprocesses a single use device that has previously been used
on a patient;
(5) Acts as an initial importer as defined in Sec. 807.3(g),
except that initial importers are not required to provide device
listings for any device for which they did not initiate or develop the
specifications for the device or repackage or relabel the device.
However, the initial importer shall submit, for each such device, the
name and address of the manufacturer. Initial importers shall also be
prepared to submit, when requested by FDA, the proprietary name, if
any, and the common or usual name of each device for which they are the
initial importer;
(6) Manufactures components or accessories that are ready to be
used for any intended health-related purpose and are packaged or
labeled for commercial distribution for such health-related purpose,
e.g. blood filters, hemodialysis tubing, or devices which of necessity
must be further processed by a licensed practitioner or other qualified
person to meet the needs of a particular patient, e.g., a manufacturer
of ophthalmic lens blanks.
(b) Registration or listing does not constitute an admission or
agreement or determination that a product is a device within the
meaning of section 201(h) of the act.
(c) Registration and listing requirements shall not pertain to any
person who acts as a wholesale distributor, as defined in Sec.
807.3(t), and who does not manufacture, repackage, process, or relabel
a device.
(d) Owners and operators of establishments or persons engaged in
the recovery, screening, testing, processing, storage, or distribution
of human cells, tissues, and cellular and tissue-based products, as
defined inSec. 1271.3(d) of this chapter, that are regulated under the
Federal Food, Drug, and Cosmetic Act must register and list those human
cells, tissues, and cellular and tissue-based products with the Center
for Biologics Evaluation and Research on Form FDA 3356 following the
procedures set out in subpart B of part 1271 of this chapter, instead
of the procedures for registration and listing contained in this part,
except that the additional listing information requirements of Sec.
807.26 remain applicable.
(e) Owners and operators of establishments that manufacture devices
licensed under section 351 of the Public Health Service Act as well as
licensed biological products used in the manufacture of a licensed
device must register and list following the procedures set out in part
607 of this chapter, instead of the procedures for registration and
listing contained in this part.
Sec. 807.22 [Removed]
4. Remove Sec. 807.22.
Sec. 807.21 [Redesignated as Sec. 807.22]
5. Redesignate Sec. 807.21 as Sec. 807.22.
[[Page 14536]]
6. Add new Sec. 807.21 to subpart B to read as follows:
Sec. 807.21 How to register establishments and list devices.
(a) Owners or operators of establishments that are subject to the
registration and listing requirements of this part must provide the
following information to us using our electronic device registration
and listing system, except as provided in paragraphs (b), (c), and (d)
of this section:
(1) Initial establishment registration information as required by
Sec. Sec. 807.22(a) and 807.25;
(2) Updates to registration information as required by Sec.
807.22(b) and 807.25;
(3) Initial device listing information as required by Sec.
807.22(a), 807.25, and 807.28;
(4) Updates to device listing information as required by Sec.
807.22(b), 807.25, and 807.28, including updates to reflect the
discontinuance or resumption of the commercial distribution of a
previously-listed device as specified at paragraphs (d) and (e) of
Sec. 807.28.
(b) If the information under Sec. 807.21(a) cannot be submitted
electronically, a waiver may be requested. Waivers will be granted only
if use of electronic means is not reasonable for the person requesting
the waiver. To request a waiver, applicants must send a letter to the
Office of Compliance, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Building 66, rm.
2621, Silver Spring, MD 20993-0002, that includes the following
information:
(1) The name and address of the device establishment(s) to be
registered, a contact person for the owner or operator of the
establishment, and the telephone number at which that person can be
reached. If the establishment has already registered in the past, the
letter should also include the owner or operator number, registration
number, and any listing numbers previously assigned by FDA for that
establishment.
(2) Information about whether the company is an initial importer as
defined in Sec. 807.3(g) and, if so, whether it also conducts any
other activities or operations relating to devices.
(3) A statement that use of the Internet is not reasonable for the
person requesting the waiver, and an explanation of why such use is not
reasonable. The statement must be signed by the owner or operator of
the establishment, or by a person employed by the owner or operator who
is authorized to make the declaration on behalf of the owner or
operator.
(c) Those owners or operators who have obtained a waiver from
filing registration and listing information electronically should refer
to Sec. 807.34 for information on how to submit such information by
postal mail.
(d) When additional device listing information (e.g., copies of
labeling or advertisements) is requested by FDA as described at Sec.
807.26(e), such information may be submitted by postal mail or
electronically by e-mail, but will not be submitted using the FDA
electronic device registration and listing system.
7. Revise newly redesignated Sec. 807.22 to read as follows:
Sec. 807.22 Times for establishment registration and device listing.
(a) Initial registration and listing. An owner or operator of an
establishment who has not previously entered into an operation
described in Sec. 807.20(a) shall register within 30 days after
entering into such an operation and submit device listing information
at that time.
(b) Registration and listing updates. Owners or operators shall
review and update all of their establishment registration and device
listing information that is on file at FDA, documenting any changes
that were not previously reported as follows:
(1) Annual registration for each fiscal year is required for all
establishments. Annual registration shall take place during the period
beginning on October 1 and ending on December 31 of each fiscal year;
(2) Updates to the registration information as described in Sec.
807.25(b) shall be made within 30 days of any change to such
information;
(3) Every fiscal year, during the period beginning on October 1 and
ending on December 31, owners or operators shall review and update all
of their device listing information that is on file at FDA, reporting
any changes or deletions to listings and any new listings that were not
previously reported. The accuracy of all information on file must be
confirmed each year regardless of whether any changes were made to the
owner or operator's list of devices; and
(4) Changes to listing information may also be made at other times,
such as when a device is introduced into commercial distribution, when
a change is made to a previously-listed device, or when a previously-
listed device is removed from commercial distribution.
(c) Failure to submit any of the required information on time, as
specified in paragraphs (a) and (b) of this section, will put the
establishment in a ``failed to register'' or ``failed to list'' status
as applicable. The establishment will not be considered active and the
establishment registration and device listing information will not
appear on the FDA Web site until such time as the owner or operator
submits and FDA processes the required information.
8. Revise Sec. 807.25 to read as follows:
Sec. 807.25 Information required for establishment registration and
device listing.
(a) All owners or operators that are subject to the registration
and listing requirements of this part shall provide such information to
us by using the FDA electronic device registration and listing system,
unless granted a waiver from electronic submission in accordance with
Sec. 807.21(b). Electronic submissions of registration and listing
information must comply with part 11 of this chapter, except for the
requirements in Sec. 11.10(b), (c), and (e), and the corresponding
requirements in Sec. 11.30. Those owners or operators granted a waiver
from electronic submission should refer to paragraphs (c) and (g) of
this section and Sec. 807.34 for instructions on how to submit device
registration and listing information.
(b) Registration information required to be submitted includes: The
name and mailing address of the device establishment; the Web site
address of the device establishment, if any; the name, address, phone
number, fax number, and e-mail address of the owner or operator; the
name, address, phone number; fax number, and e-mail address of the
establishment's official correspondent; and all trade names used by the
establishment.
(c) Owners or operators who have been granted a waiver from
electronic filing must submit the establishment registration
information described in paragraph (b) of this section, except for the
Web site and e-mail address information, in paper form using the
procedures set forth in Sec. 807.34.
(d) Each owner or operator is required to maintain a listing of all
officers, directors, and partners for each establishment registered by
the owner or operator and to furnish this information to FDA upon
request.
(e) For each establishment, an official correspondent must be
designated by the owner or operator to serve as a point of contact with
FDA on matters relating to the registration of device establishments
and the listing of device products. Each owner or operator shall also
provide FDA with the name of a contact person at the owner or
operator's offices who will be responsible for identifying the official
correspondent for each establishment. The owner or operator contact
person
[[Page 14537]]
will be the official correspondent in the event no one else has been
properly designated. The official correspondent is responsible for:
(1) Providing FDA with all required registration and listing
information electronically unless a waiver from electronic submission
has been granted in accordance with Sec. 807.21(b) ;
(2) Receiving all correspondence from FDA concerning registration
and listing;
(3) Supplying, when requested by FDA, the names of all officers,
directors, and partners; and
(4) Receiving communications from FDA by e-mail, or by postal mail
if the owner or operator has been granted a waiver from the requirement
to file registration and listing information electronically.
(f) The designation of an official correspondent does not in any
manner affect the liability of the owner or operator of the
establishment or any other individual under section 301(p) or any other
provision of the act.
(g) Device listing information must be submitted to FDA
electronically unless a waiver from electronic submission has been
granted in accordance with Sec. 807.21(b). Owners or operators who
have been granted a waiver must submit the required device listing
information, including information required by this paragraph, Sec.
807.28, and any listing information requested by FDA under Sec.
807.26(e), in paper form using the procedures set forth in Sec.
807.34. The information required for each device listed includes:
(1) The current registration number and name of each establishment
under the ownership and control of the owner or operator where the
device is manufactured, repackaged, relabeled, or otherwise processed,
or where specifications are developed.
(2) The product code for each device that is exempt from premarket
notification and approval or which was in commercial distribution prior
to May 28, 1976.
(3) The proprietary or brand name(s) under which each device is
marketed.
(4) The FDA-assigned premarket submission number of the approved
application, cleared premarket notification, or approved humanitarian
device exemption for each device listed that is subject to sections
505, 510, 515, or 520 of the act, which includes devices that are not
exempt from premarket notification and approval.
(5) Each activity or process that is conducted on or done to the
device at each establishment, such as manufacturing, repacking,
relabeling, developing specifications, remanufacturing, single-use
device reprocessing, contract manufacturing, contract sterilizing, or
manufacturing for export only.
Sec. 807.26 [Removed and Reserved]
9. Remove and reserve Sec. 807.26.
Sec. 807.31 [Redesignated as Sec. 807.26]
10. Redesignate Sec. 807.31 as Sec. 807.26.
11. Amend newly redesignated Sec. 807.26 by adding paragraph (f)
to read as follows:
Sec. 807.26 Additional listing information.
* * * * *
(f) Labeling, advertisements, and other information to be submitted
upon request in accordance with paragraph (e) of this section may be
submitted by postal mail or electronically by e-mail, but will not be
submitted using the FDA electronic device registration and listing
system. Electronic submissions of such information must comply with
part 11 of this chapter, except for the requirements in Sec. 11.10
(a), (c) through (h), and (k), and the corresponding requirements in
Sec. 11.30. The information provided in electronic format must be in a
form that we can process, review, and archive.
Sec. 807.30 [Redesignated as Sec. 807.28]
12. Redesignate Sec. 807.30 as Sec. 807.28.
13. Revise newly redesignated Sec. 807.28 to read as follows:
Sec. 807.28 Updating device listing information.
(a) Updating of device listing information is required when an
additional establishment begins to engage in any of the activities
described in Sec. 807.3(d) with respect to a listed device, such as
manufacturing, developing specifications, repackaging, relabeling, or
otherwise processing the device. Updating of the listing is also
required when an establishment begins performing another activity on or
to the device, or ceases to perform an activity on or to the device
that had previously been identified on the device listing.
(b) An owner or operator shall create a new device listing using
the FDA electronic device registration and listing system:
(1) When introducing into commercial distribution an exempt device
identified with a product code that is not currently listed by the
owner or operator; or
(2) When introducing into commercial distribution a non-exempt
device with an FDA premarket submission number that is not currently
listed by the owner or operator.
(c) All device listings for foreign establishments must be
submitted before the device may be imported or offered for import into
the United States.
(d) An owner or operator who discontinues commercial distribution
of a device shall discontinue the device listing using the FDA
electronic device registration and listing system. A device listing is
considered discontinued if:
(1) All devices under an exempt product code have been discontinued
or
(2) All devices associated with an FDA premarket submission number
have been discontinued.
(e) If commercial distribution of a discontinued device is resumed,
the owner or operator must reactivate the previously-discontinued
listing using the electronic device registration and listing system.
Any changes to the listing information for the product that is the
subject of the listing such as a new establishment, new activity, or
new proprietary name must be made using the electronic device
registration and listing system at the time the listing is reactivated.
(f) FDA will assign one listing number for all devices exempt from
premarket notification requirements under a single product code. For
products not exempt from premarket notification requirements, a single
listing number will be assigned by FDA for each FDA premarket
submission number.
14. Add Sec. 807.34 to subpart B to read as follows:
Sec. 807.34 Summary of requirements for owners or operators granted a
waiver from submitting required information electronically.
(a) For initial registration and listing, owners or operators who
have been granted a waiver from electronic filing using the procedures
set forth in Sec. 807.21(b) must send a letter containing all of the
registration and listing information described in Sec. Sec. 807.22,
807.25, (and Sec. 807.26 when such information is requested by FDA),
at the times described in Sec. 807.22, to: The Office of Compliance,
Center for Devices and Radiological Health (HFZ-308), Food and Drug
Administration, 10903 New Hampshire Ave., Building 66, room 3521,
Silver Spring, MD 20993-0002.
(b) As specified in Sec. 807.22(b)(1) and (b)(3), all owners or
operators shall update their establishment registration and device
listings annually during the period beginning on October 1 and ending
on December 31 of each fiscal year.
(c) Failure to submit any of the required information on time, as
specified in Sec. 807.22(a) and (b), will put the establishment in a
``failed to register'' or ``failed to list'' status as applicable.
[[Page 14538]]
The establishment will not be considered active and the establishment
registration and device listing information will not appear on the FDA
Web site until the required information is submitted to and processed
by FDA.
15. Amend Sec. 807.35 by revising paragraphs (a) and (b) to read
as follows:
Sec. 807.35 Notification of registrant.
(a) FDA will assign each device establishment a permanent
registration number after verifying the initial establishment
registration information that has been submitted. The owner or operator
of the establishment will also be assigned an identifying number. Both
numbers will be sent to the official correspondent by e-mail, or by
postal mail if the owner or operator has been granted a waiver from the
requirement to file registration and listing information
electronically.
(b) Owners or operators of device establishments who also
manufacture or process biological products (including devices licensed
under section 351 of the Public Health Service Act) or drug products at
the same establishment must also register and list those products under
part 607 or part 207 of this chapter, as appropriate. Registration and
listing for human blood and blood products, devices licensed under
section 351 of the Public Health Service Act, and licensed biological
products used in the manufacture of a device licensed under section 351
of the Public Health Service Act, are subject to part 607 of this
chapter; registration and listing for all other drug products
(including other biological products that are also regulated as drug
products) are subject to part 207 of this chapter.
* * * * *
16. Revise Sec. 807.37 to read as follows:
Sec. 807.37 Public availability of establishment registration and
device listing information.
Establishment registration and device listing information is
available for public inspection in accordance with section 510(f) of
the act and will be posted on the FDA Web site. Requests for
information by persons who do not have access to the Internet should be
directed to the Office of Compliance, Center for Devices and
Radiological Health (HFZ-308), Food and Drug Administration, 10903 New
Hampshire Ave., Building 66, rm. 3521, Silver spring, MD 20993-0002. In
addition, there will be available for inspection at each of the Food
and Drug Administration district offices the same information for firms
within the geographical area of such district offices. Upon request,
verification of a registration number or location of a registered
establishment will be provided.
17. The heading of subpart C is revised to read as set forth below:
Subpart C--Procedures for Foreign Device Establishments
18. Amend Sec. 807.40 by revising paragraphs (a) and (c) and by
adding paragraph (d) to read as follows:
Sec. 807.40 Establishment registration and device listing for foreign
establishments importing or offering for import devices into the United
States.
(a) Any establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or processing of a
device that is imported or offered for import into the United States
shall register such establishment and list such devices using the FDA
electronic device registration and listing system in conformance with
the procedures in this section, Sec. 807.41, and subpart B of this
part. The official correspondent for the foreign establishment shall
facilitate communication between the foreign establishment's management
and representatives of the Food and Drug Administration for matters
relating to the registration of device establishments and the listing
of device products.
* * * * *
(c) No device may be imported or offered for import into the United
States unless it is the subject of a device listing as required under
subpart B of this part and is manufactured, prepared, propagated,
compounded, or processed at a registered foreign establishment;
however, this restriction does not apply to devices imported or offered
for import under the investigational use provisions of part 812 of this
chapter.
(d) The establishment registration and device listing information
shall be in the English language.
19. Add Sec. 807.41 to subpart C to read as follows:
Sec. 807.41 Identification of importers and persons who import or
offer for import.
(a) Upon initial registration, annually, and at the time of any
changes, each foreign establishment required to register and list as
provided in Sec. 807.40(a) must, using the FDA electronic device
registration and listing system, submit the name, address, telephone
and fax numbers, e-mail address, and registration number, if any has
been assigned, of any importer (defined in Sec. 807.3(x)) of the
establishment's devices that is known to the foreign establishment. The
foreign establishment must also specify which of the establishment's
listed products each importer receives from the foreign establishment.
(b) Upon initial registration, annually, and at the time of any
changes, each foreign establishment required to register and list as
provided in Sec. 807.40(a) must, using the FDA electronic device
registration and listing system, submit the name, address, telephone
and fax numbers, e-mail address, and registration number, if any has
been assigned, of each person who imports or offers for import the
establishment's devices into the United States. The term ``person who
imports or offers for import,'' which is defined in Sec. 807.3(y),
includes agents, brokers, or other parties used by the foreign
establishment to facilitate the import of its device into the United
States.
(c) For each individual or organization identified by the foreign
establishment under paragraphs (a) and (b) of this section, the foreign
establishment must submit to FDA electronically the current FDA
premarket submission number (e.g., PMA, 510(k), HDE, NDA) and any other
identifying information that is known to the establishment for each
device being imported or offered for import by the named individuals or
organizations.
Dated: March 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6662 Filed 3-25-10; 8:45 am]
BILLING CODE 4160-01-S