[Federal Register Volume 63, Number 80 (Monday, April 27, 1998)]
[Rules and Regulations]
[Pages 20530-20533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11086]


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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: Direct 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 
application (PMA) supplements to allow 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). FDA is 
publishing these amendments in accordance with its direct final rule 
procedures. Elsewhere in this issue of the Federal Register, FDA is 
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 the agency receives any significant adverse

[[Page 20531]]

comment and withdraws the direct final rule.

DATES: The direct final rule is effective September 9, 1998. Submit 
written comments on or before July 13, 1998. Submit written comments on 
the information collection requirements on or before June 26, 1998. If 
FDA receives no significant adverse comment within the specified 
comment period, the agency intends 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.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

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 all changes that affect safety and 
effectiveness unless such changes involve modifications to 
manufacturing procedures or method of manufacture. Those types of 
manufacturing changes will require a 30-day notice or, where FDA finds 
such notice inadequate, a 135-day PMA supplement. Examples of changes 
that potentially qualify for a 30-day notice are those intended by the 
PMA holder to reduce manufacturing and/or labor cost, reduce 
manufacturing time, reduce waste, or compensate for a change in 
suppliers of raw material or components.
    Manufacturers who believe that the change they intend to make 
qualifies for this review will be required to submit a 30-day notice to 
FDA that describes in detail the change the manufacturer intends to 
make, summarizes the data or information supporting the change, and 
states 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 not 
adequate. If the notice is not adequate, FDA will inform the applicant 
in writing that a 135-day supplement is needed and will describe what 
further action or information is required for FDA to approve the 
change. The time FDA uses to review the 30-day notice will be deducted 
from the 135-day supplement review period if the notice contains the 
appropriate information that is required for review of PMA supplements.
    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).
    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 it has announced the availability of the guidance in 
the Federal Register of February 25, 1998 (63 FR 9570).

II. Rulemaking Action

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA 
described when and how it will employ direct final rulemaking. FDA 
believes that this rule is appropriate for direct final rulemaking 
because FDA views this rule as making noncontroversial amendments to an 
existing rule, incorporating amendments to section 515 of the act made 
by FDAMA. FDA anticipates no significant adverse comment on this rule. 
Consistent with FDA's procedures on direct final rulemaking, FDA is 
publishing elsewhere in this issue of the Federal Register a companion 
proposed rule to amend 21 CFR part 814. This direct final rule is 
substantively identical to the companion proposed 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 
a significant adverse comment. The comment period for the direct final 
rule runs concurrently with that for the companion proposed rule. Any 
comments received on the companion proposed rule will be treated as 
comments on the direct final rule.
    FDA is providing a comment period on the direct final rule of 75 
days after April 27, 1998. If the agency receives a significant adverse 
comment, FDA intends to withdraw this final rule by publication of a 
notice in the Federal Register within 30 days after the comment period 
ends. A significant 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 a significant adverse comment is 
sufficient to terminate a direct final rulemaking, FDA will consider 
whether the comment raises an issue serious enough to warrant a 
substantive response in a notice-and-comment process. For example, a 
comment recommending an additional change to the rule may be considered 
a significant adverse comment if the comment demonstrates 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, FDA may adopt as final those 
parts of the rule that are not the subject of a significant adverse 
comment. Comments that are frivolous, insubstantial, or outside the 
scope of the rule will not be considered significant or adverse under 
this procedure.
    If FDA withdraws the direct final rule, all comments received will 
be applied to the proposed rule and will be considered in developing a 
final rule using the agency's usual notice and comment procedures. If 
FDA receives no significant adverse comment during the specified 
comment period, FDA intends to publish a confirmation notice within 30 
days after the comment period ends confirming that the direct final 
rule will go into effect on September 9, 1998.

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 of available regulatory alternatives and, when regulatory action 
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 final rule is consistent with the 
regulatory philosophy and principles identified in the Executive Order. 
In addition, this direct final rule is not a significant regulatory 
action as defined by the Executive Order and so is not

[[Page 20532]]

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 the FDAMA. The Commissioner of Food and Drugs 
certifies that this final rule will not have a significant economic 
impact on a substantial number of small entities. This direct 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 direct 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 below 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.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of the agency's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and, (4) ways to minimize 
the burden of the collection of information on respondents, including 
through the use of automated collection techniques, when appropriate, 
and other forms of information technology.
    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 premarket approval 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.
    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 information 
collection requirements in Sec. 814.39 is 32,612, for a reduction of 
3,451 hours.
    As provided in 5 CFR 1320.5(c)(1), collections of information in a 
direct final rule are subject to the procedures set forth in 5 CFR 
1320.10. Interested persons and organizations may submit comments on 
the information collection requirements of this direct final rule by 
June 26, 1998 to the Dockets Management Branch (address above). At the 
close of the 60-day comment period, FDA will review the comments 
received, revise the information collection provisions as necessary, 
and submit these provisions to OMB for review. FDA will publish a 
notice in the Federal Register when the information collection 
provisions are submitted to OMB, and an opportunity for public comment 
to OMB will be provided at that time. Prior to the effective date of 
the direct final rule, FDA will publish a notice in the Federal 
Register of OMB's decision to approve, modify, or disapprove the 
information collection provisions. 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.

VI. Comments

    Interested persons may by July 13, 1998, submit to the Dockets 
Management Branch (address above) written comments regarding this rule. 
This comment period runs concurrently with the comment period for the 
companion proposed rule. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in the brackets in the 
heading of this document. Received comments may be seen in the office 
above between 9 a.m. and 4 p.m., Monday through Friday. All comments 
received will be considered comments regarding the proposed rule and 
this direct final rule. In the event the direct final rule is 
withdrawn, all comments received regarding the

[[Page 20533]]

companion proposed rule and the direct final rule will be considered 
comments on the proposed rule.

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.

    2. Section 814.39 is amended by revising the introductory text of 
paragraph (a) and paragraph (a)(4) and by adding paragraph (f) 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:
* * * * *
    (4) Changes in manufacturing facilities, methods, or quality 
control procedures that do not meet the requirements for a submission 
under paragraph (e) or (f) of this section.
* * * * *
    (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 21 CFR part 820. 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: March 24, 1998.
 William B. Schultz,
 Deputy Commissioner for Policy.
[FR Doc. 98-11086 Filed 4-24-98; 8:45 am]
BILLING CODE 4160-01-F