[Federal Register Volume 73, Number 115 (Friday, June 13, 2008)]
[Proposed Rules]
[Pages 33749-33751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13349]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 803
[Docket No. FDA-2008-N-0310]
Medical Devices; Medical Device Reporting; Baseline Reports;
Companion to Direct Final Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its medical device reporting regulations to remove a requirement for
baseline reports that the agency deems no longer necessary. Currently,
manufacturers provide baseline reports to FDA that include the FDA
product code and the premarket approval or premarket notification
number. Because most of the information in these baseline reports is
also submitted to FDA in individual adverse event reports, FDA is
proposing to remove the requirement for baseline reports. The removal
of this requirement would eliminate unnecessary duplication and reduce
the manufacturer's reporting burden. This proposed rule is a companion
document to the direct final rule published elsewhere in this issue of
the Federal Register.
DATES: Submit written or electronic comments by August 27, 2008.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0310, by any of the following methods:
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.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and Docket No. 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 section IX 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: Howard A. Press, Center for Devices
and Radiological Health (HFZ-530), Food and Drug Administration, 1350
Piccard Dr, Rockville, MD 20850, 240-276-3457.
[[Page 33750]]
SUPPLEMENTARY INFORMATION:
I. Why Is This Companion Proposed Rule Being Issued?
This proposed rule is a companion to the direct final rule
regarding baseline reporting requirements for medical devices that is
published in the final rules section of this issue of the Federal
Register. The direct final rule and this companion proposed rule are
substantively identical. This companion proposed rule provides the
procedural framework to finalize the rule in the event that the direct
final rule receives any significant adverse comment and is withdrawn.
We are publishing the direct final rule because we believe the rule is
noncontroversial, and we do not anticipate receiving any significant
adverse comments. If no significant adverse comment is received in
response to the direct final rule, no further action will be taken
related to this proposed rule. Instead, we will publish a confirmation
document within 30 days after the comment period ends confirming when
the direct final rule will go into effect.
If we receive any significant adverse comment regarding the direct
final rule, we will withdraw the direct final rule within 30 days after
the comment period ends and proceed to respond to all of the comments
under this companion proposed rule using usual notice-and-comment
rulemaking procedures under the Administrative Procedure Act (APA) (5
U.S.C. 552a et seq). The comment period for this companion proposed
rule runs concurrently with the direct final rule's comment period. Any
comments received under this companion proposed rule will also be
considered as comments regarding the direct final rule and vice versa.
We will not provide additional opportunity for comment.
A significant adverse comment is defined as a comment that explains
why the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without a change. In determining whether an adverse comment is
significant and warrants withdrawing a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process in accordance
with section 553 of the APA (5 U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the scope of the rule will not be
considered adverse under this procedure. For example, a comment
recommending an additional change to the rule will not be considered a
significant adverse comment, unless the comment states why the rule
would be ineffective without the additional change. In addition, if a
significant adverse comment applies to part of a rule and that part can
be severed from the remainder of the rule, we may adopt as final those
parts of the rule that are not the subject of a significant adverse
comment.
In the Federal Register of November 21, 1997 (62 FR 62466), you can
find additional information about FDA's direct final rulemaking
procedures in the guidance document entitled ``Guidance for FDA and
Industry: Direct Final Rule Procedures.'' This guidance document may be
accessed at http://www.fda.gov/opacom/morechoices/industry/guidance.htm.
II. What Is the Background of the Proposed Rule?
In the Federal Register of December 11, 1995 (60 FR 63578), FDA
published a final rule revising part 803 (21 CFR part 803) and
requiring medical device manufacturers to submit certain reports
relating to adverse events, including a requirement under Sec. 803.55
to submit baseline reports on FDA Form 3417 or an electronic
equivalent. Section 803.55 requires manufacturers to submit baseline
reports when the manufacturer submits the first adverse event report
under Sec. 803.50 for a device model. In addition, Sec. 803.55
requires annual updates of each baseline report.
The baseline report includes address information for the reporting
and manufacturing site for the device, device identifiers, the basis
for marketing for the device (e.g., the 510(k) number or PMA number),
the FDA product code, the shelf life of the device (if applicable) and
the expected life of the device, the number of devices distributed each
year, and the method used to calculate that number. In the Federal
Register of July 31, 1996 (61 FR 39868), FDA stayed the requirement for
manufacturers to submit information on the number of devices
distributed each year and the method used to calculate that number,
because of questions raised about the feasibility of obtaining such
information and the usefulness of such information once submitted to
FDA.
With the requirement for these two data elements stayed, the data
submitted in baseline reports largely overlapped with the data
submitted in individual adverse event reports. That is, FDA had access
to much of the information included in baseline reports through the
individual adverse event reports submitted on the MedWatch mandatory
reporting form (FDA Form 3500A). Two notable exceptions were the basis
for marketing and the FDA product code, data elements that were
included in the baseline reports but were not included in the FDA Form
3500A and its instructions.
The basis for marketing and the FDA product code were, however,
subsequently incorporated into the FDA Form 3500A and its instructions.
In the Federal Register of December 27, 2004 (69 FR 77256), FDA
announced proposed modifications to FDA Form 3500A, which included
adding an entry for the basis for marketing (PMA or 510(k) number). In
the Federal Register of December 7, 2005 (70 FR 72843), FDA announced
that the Office of Management and Budget (OMB) approved these
modifications under the Paperwork Reduction Act of 1995. FDA also
modified the instructions for FDA Form 3500A to state that
manufacturers use the FDA product code when completing the entry for
``Common Device Name'' on FDA Form 3500A.
With the addition of these two data elements (basis for marketing
and FDA product code) to FDA Form 3500A and its instructions, the
information submitted in FDA Form 3500A largely replicates the
information submitted in baseline reports. As a result, the agency
deems the baseline reporting requirement in Sec. 803.55 no longer
necessary. The agency believes that removing Sec. 803.55 would reduce
the reporting burden for manufacturers without impairing the agency's
receipt of device adverse event information.
III. What Does This Companion Proposed Rule Do?
FDA proposes to remove Sec. 803.55, which requires manufacturers
to submit a baseline report when they submit the first report under
Sec. 803.50 involving a device model and provide annual updates
thereafter. In addition, FDA proposes to make conforming amendments to
Sec. Sec. 803.1(a), 803.10(c), and 803.58(b) to remove references to
baseline reports and to Sec. 803.55. Finally, FDA proposes to remove
the terms ``device family'' and ``shelf life'' from the definitions in
Sec. 803.3 because these terms are used only in the context of
baseline reports.
IV. What is the Legal Authority for This Proposed Rule?
FDA is issuing this proposed rule under the device and general
administrative provisions of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321, 331, 351, 352, 360i, 371, and 374).
[[Page 33751]]
V. What is the Environmental Impact of This Proposed Rule?
The agency has determined under 21 CFR 25.30(h) and (i) 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.
VI. What is the Economic Impact of This Proposed Rule?
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 agency believes that
this proposed rule, if finalized, would not be 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. The rule would amend the existing medical device
reporting regulation to remove Sec. 803.55, which requires that
manufacturers submit baseline reports, and make conforming amendments
to Sec. Sec. 803.1(a), 803.3, 803.10(c), and 803.58(b) to remove
references to baseline reports and to Sec. 803.55 and to remove the
terms ``device family'' and ``shelf life.'' The rule would not impose
any new requirements but instead would remove a reporting requirement
for manufacturers that FDA deems no longer necessary. The agency
certifies that the proposed 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 $127 million, using the most current (2006) 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.
VII. How Does the Paperwork Reduction Act of 1995 Apply to This
Proposed Rule?
FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by OMB under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.
VIII. What are the Federalism Impacts of This Proposed Rule?
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the rule does not contain policies that 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 has concluded
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.
IX. How Do You Submit Comments on This Proposed Rule?
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.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic comments or
submissions will be accepted by FDA only through FDMS at http://www.regulations.gov.
List of Subjects in 21 CFR Part 803
Imports, Medical devices, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA proposes
to amend 21 CFR part 803 as follows:
PART 803--MEDICAL DEVICE REPORTING
1. The authority citation for 21 CFR Part 803 continues to read as
follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
Sec. 803.1 [Amended]
2. Section 803.1 is amended in paragraph (a), in the fourth
sentence, by removing the phrase ``and baseline reports''.
Sec. 803.3 [Amended]
3. Section 803.3 is amended by removing the definitions for
``Device family'' and ``Shelf life''.
Sec. 803.10 [Amended]
4. Section 803.10 is amended by removing paragraph (c)(3) and
redesignating paragraph (c)(4) as paragraph (c)(3).
Sec. 803.55 [Removed]
5. Section 803.55 is removed.
Sec. 803.58 [Amended]
6. Section 803.58 is amended in paragraph (b)(1) by removing
``803.55,''.
Dated: June 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13349 Filed 6-12-08; 8:45 am]
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