[Federal Register Volume 63, Number 195 (Thursday, October 8, 1998)]
[Rules and Regulations]
[Pages 54042-54044]
From the Federal Register Online via the Government Publishing 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
