[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]



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 

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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.


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 
    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 

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 

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.

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:


1. The authority citation for 21 CFR part 803 continues to read as 

[[Page 33695]]

    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 

    Dated: June 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13350 Filed 6-12-08; 8:45 am]