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

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]

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