[Federal Register Volume 73, Number 115 (Friday, June 13, 2008)]
[Rules and Regulations]
[Pages 33692-33695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13350]
-----------------------------------------------------------------------
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending 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
removing the requirement for baseline reports. The removal of this
requirement will eliminate unnecessary duplication and reduce the
manufacturer's reporting burden. FDA is amending the regulation in
accordance with its direct final rule procedures. Elsewhere in this
issue of the Federal Register, we are publishing a companion proposed
rule under FDA's usual procedures for notice and comment to provide a
procedural framework to finalize the rule in the event we receive a
significant adverse comment and withdraw this direct final rule.
DATES: This rule is effective October 27, 2008. Submit written or
electronic
[[Page 33693]]
comments by August 27, 2008. If we receive no significant adverse
comments within the specified comment period, we intend to publish a
document confirming the effective date of the final rule in the Federal
Register within 30 days after the comment period on this direct final
rule ends. If we receive any timely significant adverse comment, we
will withdraw this final rule in part or in whole by publication of a
document in the Federal Register within 30 days after the comment
period ends.
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.
SUPPLEMENTARY INFORMATION:
I. What Is the Background of the 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 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 will reduce
the reporting burden for manufacturers without impairing the agency's
receipt of device adverse event information.
II. What Does This Direct Final Rulemaking Do?
In this direct final rule, FDA is removing 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, this direct final rule makes
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,
this direct final rule removes 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.
III. What Are the Procedures for Issuing a Direct Final Rule?
In the Federal Register of November 21, 1997 (62 FR 62466), FDA
announced the availability of the guidance document entitled ``Guidance
for FDA and Industry: Direct Final Rule Procedures'' that described
when and how FDA will employ direct final rulemaking. We believe that
this rule is appropriate for direct final rulemaking because it is
intended to make noncontroversial changes to existing regulations. We
anticipate no significant adverse comment.
Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule that is identical to the direct final rule. The companion
proposed rule provides a procedural framework within which the rule may
be finalized in the event the direct final rule is withdrawn because of
any significant adverse comment. The comment period for this direct
final rule runs concurrently with the comment period of the companion
proposed rule. Any comments received in response to the companion
proposed rule will also be considered as
[[Page 33694]]
comments regarding this direct final rule.
We are providing a comment period on the direct final rule of 75
days after the date of publication in the Federal Register. If we
receive any significant adverse comment, we intend to withdraw this
final rule before its effective date by publication of a notice in the
Federal Register within 30 days after the comment period ends. 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 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 Administrative Procedure Act (APA) (5 U.S.C.
553). Comments that are frivolous, insubstantial, or outside the scope
of the rule will not be considered significant or 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.
If we withdraw the direct final rule, all comments received will be
considered under the companion proposed rule in developing a final rule
under the usual notice-and-comment procedures under the APA (5 U.S.C.
552a et seq.). If we receive no significant adverse comment during the
specified comment period, we intend to publish a confirmation document
in the Federal Register within 30 days after the comment period ends.
IV. What is the Legal Authority for This Rule?
FDA is issuing this direct final 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).
V. What is the Environmental Impact of This 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 Rule?
FDA has examined the impacts of the final rule under Executive
Order 12866, 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 direct final rule is not 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 direct final rule amends the existing medical
device reporting regulation to remove Sec. 803.55, which requires that
manufacturers submit baseline reports, and makes 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.'' This final rule does not
impose any new requirements but instead removes a reporting requirement
for manufacturers that FDA deems no longer necessary. The agency
certifies 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 $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final 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 Rule?
This direct final rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget (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 Rule?
FDA has analyzed this final 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 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 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.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
803 is amended as follows:
PART 803--MEDICAL DEVICE REPORTING
0
1. The authority citation for 21 CFR part 803 continues to read as
follows:
[[Page 33695]]
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
Sec. 803.1 [Amended]
0
2. Section 803.1 is amended in paragraph (a), in the fourth sentence,
by removing the phrase ``and baseline reports''.
Sec. 803.3 [Amended]
0
3. Section 803.3 is amended by removing the definitions for ``Device
family'' and ``Shelf life''.
Sec. 803.10 [Amended]
0
4. Section 803.10 is amended by removing paragraph (c)(3) and
redesignating paragraph (c)(4) as paragraph (c)(3).
Sec. 803.55 [Removed]
0
5. Section 803.55 is removed.
Sec. 803.58 [Amended]
0
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. E8-13350 Filed 6-12-08; 8:45 am]
BILLING CODE 4160-01-S