[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]



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.


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]]


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 
    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 
    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 

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:


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

    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. E8-13349 Filed 6-12-08; 8:45 am]