Revising the Announcement Procedures for Approvals and Denials of Premarket Approval Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. 97N-0133]

Revising the Announcement Procedures for Approvals and Denials of

Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule

to revise the premarket approval application (PMA) announcement

procedure. FDA is discontinuing the publication of individual PMA

approvals and denials in the Federal Register. Instead, the agency will

announce approvals and denials of PMA's on the Internet. FDA will make

the summaries of safety and effectiveness available through the

Internet and by placing them in FDA's Dockets Management Branch. FDA

will publish in the Federal Register for each quarter a list of the

approvals and denials announced in that quarter. FDA is taking this

action in order to expedite the availability of this information.

EFFECTIVE DATE: March 2, 1998.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices

and Radiological Health (HFZ-215), Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of December 12, 1980 (45 FR 81769 at

81772), FDA prescribed the contents of a PMA and the criteria for

approving, disapproving, or withdrawing approval of a PMA. FDA

acknowledged that, although the statute does not require it to publish

the approval of a PMA in the Federal Register, section 515(d)(3) of the

Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(3))

permits an interested person to obtain review of an approved PMA.

Consequently, FDA proposed to announce approval of any PMA in the

Federal Register and to include in the announcement notice of

opportunity to petition for administrative review under section 515(g)

of the act. (See 45 FR 81769 at 81772 and 81776). FDA also proposed to

publish notice of any denial of approval or proposed withdrawal of

approval of any PMA in the Federal Register and to include in the

announcement notice of opportunity for administrative review under

section 515(g) of the act. (See 45 FR 81769 at 81773 and 81777.)

Subsequently, in the Federal Register of July 22, 1986 (51 FR 26342),

FDA issued a final rule providing, among other things, that notice of

approval of a PMA, notice of an order denying approval of a PMA, and

notice of an order withdrawing approval of a PMA will be published in

the Federal Register. (See 21 CFR 814.44(d), 814.45(d), and 814.46(e).)

In the Federal Register of June 27, 1997 (62 FR 34680), FDA issued a

proposed rule to revise the PMA announcement procedure by discontinuing

publication of PMA approvals and denials in the Federal Register and,

instead, announcing them on the Internet. Interested persons were given

until September 25, 1997, to comment on the proposed regulation. FDA

received two comments supporting the proposal, one from an in vitro

diagnostic manufacturer and the other from a dental association.

II. Summary of the Final Rule

FDA is discontinuing publication of individual PMA approvals and

denials in the Federal Register. Instead, FDA will notify the public of

PMA approvals and denials by posting them on FDA's home page on the

Internet (http://www.fda.gov), by placing the summaries of safety and

effectiveness on the Internet and in FDA's Dockets Management Branch,

and by publishing in the Federal Register after each quarter a list of

the PMA approvals and denials announced in that quarter.

FDA believes that this procedure will expedite public notification

of these actions because announcements can be placed on the Internet

more quickly than they can be published in the Federal Register, and

FDA believes that the Internet is accessible to more people than is the

Federal Register.

In accordance with section 515(d)(3) of the act, notification of an

order approving, denying, or withdrawing approval of a PMA will

continue to include a notice of opportunity to request review of the

order under section 515 (g) of the act. The 30-day period for

requesting reconsideration of an FDA action under Sec. 10.33(b) (21 CFR

10.33(b)) for notices announcing approval of a PMA will begin on the

day the notice is placed on the Internet. Section 10.33(b) provides

that FDA may, for good cause, extend this 30-day period.

Reconsideration of a denial or withdrawal of approval of a PMA may be

sought only by the applicant, in these cases, the 30-day period will

begin when the applicant is notified by FDA in writing of its decision.

III. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(8) 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

required.

IV. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive

Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).

Executive Order 12866 directs agencies to assess all costs and benefits

of available regulatory alternatives and, when regulation is necessary,

to selects regulatory

[[Page 4572]]

approaches that maximize net benefits (including potential economic,

environmental, public health and safety, and other advantages;

distributive impacts; and equity). The agency believes that the final

rule is consistent with 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. Because the final rule involves a minor procedural

change that primarily affects FDA and has no direct effect on small

companies, the agency certifies that the final rule will not have a

significant economic impact on a substantial number of small entities.

Therefore, under the Regulatory Flexibility Act, no further analysis is

required.

V. Paperwork Reduction Act of 1995

This final rule contains no additional information collection

requirements which are subject to review by the Office of Management

and Budget under the Paperwork Reduction Act of 1995 (Pub. L. 104-13).

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 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 814.44 is amended by revising paragraph (d) to read as

follows:

Sec. 814.44 Procedures for review of a PMA.

* * * * *

(d)(1) FDA will issue to the applicant an order approving a PMA if

none of the reasons in Sec. 814.45 for denying approval of the

application applies. FDA will approve an application on the basis of

draft final labeling if the only deficiencies in the application

concern editorial or similar minor deficiencies in the draft final

labeling. Such approval will be conditioned upon the applicant

incorporating the specified labeling changes exactly as directed and

upon the applicant submitting to FDA a copy of the final printed

labeling before marketing. FDA will also give the public notice of the

order, including notice of and opportunity for any interested persons

to request review under section 515(d)(3) of the act. The notice of

approval will be placed on FDA's home page on the Internet (http://

www.fda.gov), and it will state that a detailed summary of information

respecting the safety and effectiveness of the device, which was the

basis for the order approving the PMA, including information about any

adverse effects of the device on health, is available on the Internet

and has been placed on public display, and that copies are available

upon request. FDA will publish in the Federal Register after each

quarter a list of the approvals announced in that quarter. When a

notice of approval is published, data and information in the PMA file

will be available for public disclosure in accordance with Sec. 814.9.

(2) A request for copies of the current PMA approvals and denials

document and for copies of summaries of safety and effectiveness shall

be sent in writing to the Dockets Management Branch (HFA-305), Food and

Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

* * * * *

3. Section 814.45 is amended by revising paragraph (d) to read as

follows:

Sec. 814.45 Denial of approval of a PMA.

* * * * *

(d)(1) FDA will give the public notice of an order denying approval

of the PMA. The notice will be placed on the FDA's home page on the

Internet (http://www.fda.gov), and it will state that a detailed

summary of information respecting the safety and effectiveness of the

device, including information about any adverse effects of the device

on health, is available on the Internet and has been placed on public

display and that copies are available upon request. FDA will publish in

the Federal Register after each quarter a list of the denials announced

in that quarter. When a notice of denial of approval is made publicly

available, data and information in the PMA file will be available for

public disclosure in accordance with Sec. 814.9.

(2) A request for copies of the current PMA approvals and denials

document and copies of summaries of safety and effectiveness shall be

sent in writing to the Freedom of Information Staff (HFI-35), Food and

Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

* * * * *

Dated: January 22, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98-2263 Filed 1-29-98; 8:45 am]

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