[Federal Register Volume 63, Number 195 (Thursday, October 8, 1998)]
[Rules and Regulations]
[Pages 54042-54044]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-26928]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. 98N-0168]


Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations governing the submission and review of premarket approval 
(PMA) supplements to provide for the submission of a 30-day notice for 
modifications to manufacturing procedures or methods of manufacture. 
Amendments are being made to implement revisions to the Federal Food, 
Drug, and Cosmetic Act (the act) as amended by the Food and Drug 
Administration Modernization Act of 1997 (FDAMA).

EFFECTIVE DATE: November 9, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kathy M. Poneleit, Center for Devices 
and Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2186.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, the President signed FDAMA (Pub. L. 105-115) 
into law. As one of its provisions, FDAMA added section 515(d)(6) to 
the act (21 U.S.C. 360e(d)(6)). This new section provides that PMA 
supplements are required for any change to a device that affect safety 
and effectiveness unless such change involves modifications to 
manufacturing procedures or method of manufacture. Such changes to 
manufacturing procedures or method of manufacture will require a 30-day 
notice or, where FDA finds such notice inadequate, a 135-day PMA 
supplement.
    The agency has developed guidance on this issue entitled ``CDRH 
Guidance for 30-Day notices and 135-Day PMA Supplements for 
Manufacturing Method or Process Changes for Use by OC, ODE, and 
Industry,'' and has announced the availability of the guidance in the 
Federal Register of February 26, 1998 (63 FR 9570).
    On April 27, 1998, FDA published a proposed rule (63 FR 20558) and 
a direct final rule (63 FR 20530) to implement the amendments to the 
PMA provisions. FDA received a single comment, which the agency deemed 
to be significant. Accordingly, consistent with FDA's procedures on 
direct final rulemaking, FDA is withdrawing the direct final rule and 
is addressing the comment in this final rule based upon the April 27, 
1998, proposed rule previously referenced. This rule incorporates the 
provisions for a 30-day notice and 135-day PMA supplements into FDA's 
regulations at Sec. 814.39 (21 CFR 814.39).

II. Summary of Comments

    The agency received one comment, which stated that the list of 
examples of changes affecting the safety or effectiveness of a device 
which would require the submission of a PMA supplement, provided in 
Sec. 814.39(a), should not include the language in proposed 
Sec. 814.39(a)(4) which states: ``Changes in manufacturing facilities, 
methods, or quality control procedures that do not meet the 
requirements for a submission under paragraphs (e) or (f) of this 
section.'' The comment states that no submissions are required for 
changes that do not affect safety or effectiveness and, under FDAMA, 
changes in manufacturing facilities, methods, or quality control 
procedures which DO affect the safety or effectiveness of the device 
may be filed with a 30-day notice. Therefore, proposed 
Sec. 814.39(a)(4) does not apply to any submissions, and should be 
removed.
    The agency agrees and is removing proposed Sec. 814.39(a)(4) from 
the list of changes which require the submission of a PMA supplement. 
The agency stresses, however, that the 30-day notice procedure is 
restricted to changes only in manufacturing procedures and

[[Page 54043]]

methods of manufacture. A PMA supplement would be required if multiple 
changes are made to a device, even if such changes include changes in 
manufacturing procedures or methods of manufacture along with other 
changes which would otherwise require a PMA supplement.

III. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not cumulatively have a significant effect on the 
human environment. Therefore, neither an environmental assessment nor 
an environmental impact statement is required.

IV. Analysis of Impacts

    FDA has examined the impacts of this final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all 
costs and benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The agency believes that this final rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. In addition, the final rule is not a significant regulatory 
action as defined by the Executive Order and so is not subject to 
review under 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 merely codifies applicable statutory 
requirements imposed by FDAMA. The agency certifies that this final 
will not have a significant economic impact on a substantial number of 
small entities. This final rule also does not trigger the requirement 
for a written statement under section 202(a) of the Unfunded Mandates 
Reform Act because it does not impose a mandate that results in an 
expenditure of $100 million or more by State, local, or tribal 
governments in the aggregate, or by the private sector, in any 1 year.

V. Paperwork Reduction Act of 1995

    This final 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). The title, 
description, and respondent description of the information collection 
provisions are shown as follows along with an estimate of the annual 
reporting 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.
    Title: Supplements to Premarket Approval Applications for Medical 
Devices
    Description: FDAMA added section 515(d)(6) to the act, modifying 
FDA's statutory authority regarding PMA of medical devices. This new 
section provides for an alternate form of notice to the agency for 
certain types of changes to a device for which the manufacturer has an 
approved PMA. Under this section, PMA supplements are required for all 
changes that affect safety and effectiveness unless such changes 
involve modifications to manufacturing procedures or the method of 
manufacture. For those types of manufacturing changes, the manufacturer 
may submit to the agency an alternate form of notice in the form of a 
30-day notice or, where FDA finds such notice inadequate, a 135-day PMA 
supplement. The 30-day notice must describe the change the manufacturer 
intends to make, summarize the data or information supporting the 
change, and state that the change has been made in accordance with the 
requirements of part 820 (21 CFR part 820).
    The manufacturer may distribute the device 30 days after FDA 
receives the notice, unless FDA notifies the applicant, within that 30-
day period, that the notice is inadequate. If the notice is not 
adequate, FDA will inform the manufacturer that a 135-day supplement is 
required and will describe what additional information or action is 
necessary for FDA to approve the change.
    This rule incorporates the provisions for a 30-day notice and 135-
day supplements into FDA's regulations at Sec. 814.39 to reflect the 
changes made by FDAMA.
    Description of Respondents: Businesses or other for profit 
organizations.
    FDA estimates the burden for this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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814.39                                493               1             493              66.15       32,612
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA believes that the amendments to Sec. 814.39 permitting the 
submission of 30-day notices in lieu of PMA supplements will result in 
approximately a 10 percent reduction in the total number of hours 
needed to comply as compared to Sec. 814.39. As a result, FDA estimates 
that the new total number of hours needed to comply with information 
collection requirements in Sec. 814.39 is 32,612, for a reduction of 
3,451 hours.
    The information collection provisions of this final rule have been 
submitted to OMB for review. Prior to the effective date of this final 
rule, FDA will publish a document in the Federal Register of OMB's 
decision to approve, modify, or disapprove the information collection 
provisions in this final rule. An agency may not conduct or sponsor, 
and a person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number.

List of Subjects in 21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of the Food and Drugs, 21 
CFR part 814 is amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

    1. The authority citation for 21 CFR part 814 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 
373, 374, 375, 379, 379e, 381.


[[Page 54044]]


    2. Section 814.39 is amended by revising paragraph (a) introductory 
text, by removing paragraph (a)(4) and redesignating paragraphs (a)(5) 
through (a)(8) as paragraphs (a)(4) through (a)(7), respectively, and 
by adding paragraph (f) before the concluding text to read as follows:


Sec. 814.39  PMA supplements.

    (a) After FDA's approval of a PMA, an applicant shall submit a PMA 
supplement for review and approval by FDA before making a change 
affecting the safety or effectiveness of the device for which the 
applicant has an approved PMA, unless the change is of a type for which 
FDA, under paragraph (e) of this section, has advised that an alternate 
submission is permitted or is of a type which, under section 
515(d)(6)(A) of the act and paragraph (f) of this section, does not 
require a PMA supplement under this paragraph. While the burden for 
determining whether a supplement is required is primarily on the PMA 
holder, changes for which an applicant shall submit a PMA supplement 
include, but are not limited to, the following types of changes if they 
affect the safety or effectiveness of the device:
 * * * * *
    (f) Under section 515(d) of the act, modifications to manufacturing 
procedures or methods of manufacture that affect the safety and 
effectiveness of a device subject to an approved PMA do not require 
submission of a PMA supplement under paragraph (a) of this section and 
are eligible to be the subject of a 30-day notice. A 30-day notice 
shall describe in detail the change, summarize the data or information 
supporting the change, and state that the change has been made in 
accordance with the requirements of part 820 of this chapter. The 
manufacturer may distribute the device 30 days after the date on which 
FDA receives the 30-day notice, unless FDA notifies the applicant 
within 30 days from receipt of the notice that the notice is not 
adequate. If the notice is not adequate, FDA shall inform the applicant 
in writing that a 135-day PMA supplement is needed and shall describe 
what further information or action is required for acceptance of such 
change. The number of days under review as a 30-day notice shall be 
deducted from the 135-day PMA supplement review period if the notice 
meets appropriate content requirements for a PMA supplement.
* * * * *

    Dated: October 1, 1998.
 William B. Schultz,
 Deputy Commissioner for Policy.
[FR Doc. 98-26928 Filed 10-7-98; 8:45 am]
BILLING CODE 4160-01-F