• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages - October 10, 1997 (P97-1) (Text Only)

PMA Memorandum #P97-1

Date:October 10,1997
From:Director, Office of Device Evaluation
Subject:Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages
To:ODE Review Staff

Purpose

The purpose of this Blue Book memorandum is to announce the establishment of new procedures for distributing and making summaries of safety and effectiveness data (SSEDs) publicly available.

Background

At the present time, SSEDs are made available to the public via a Notice of Availability (NOA) published in the FEDERAL REGISTER (FR). Upon its announcement in the FR, interested parties may view an SSED in the FDA Dockets Management Branch or request a copy of the SSED under the Freedom of Information Act (FOIA).

A proposed rule was published in the FR of June 27, 1997 [Docket No. 97-0133] which, among other changes, would discontinue the FR publication of NOAs for PMA approvals and denials. In anticipation of these proposed changes, ODE recently expanded the procedures regarding the distribution and public availability of SSED packages.

An "SSED Package" intended for release to the public consists of the SSED, the approval order and the label. The SSED package is considered immediately available for public disclosure at the time it is considered final by the Director, ODE. Under this new policy, a dated copy of the final version of the SSED package is distributed and made available to the public in accordance with the following procedures.

Procedures

SSED packages will be distributed as follows:

  1. Via the Internet at the CDRH website.

    Once the SSED package is considered final by the Director, ODE, the dated copy is distributed for placement on the IMAGE system for internal use by CDRH staff and on the Internet for public access. SSED packages can be found on the Internet at the CDRH website.

  2. Via FOIA request.

    The person making a request for an SSED package should be encouraged to obtain the information, if available, from the CDRH website identified above. However, requesters who desire a hardcopy should make a formal request via FOIA. Instructions for making a FOIA request, can be found at "How to Make a FOIA Request".

    Only the finalized and dated SSED package is available for release under FOIA.

    In addition, FOIA instructions may be obtained via the FDA Facts-on-Demand (FOI Instruction Handbook - Shelf #520) at 301-827-0111 or 800-899-0381 or facsimile by contacting the PMA Staff at 301-594-2186.

  3. Via the Dockets Management Branch.

    Until finalization of the proposed rule discussed above, when an SSED package becomes available for public distribution, a Notice of Availability (NOA) will be published in the FEDERAL REGISTER. SSED packages for PMA approval and denial decisions which have been announced in the FR remain available through the Dockets Management Branch. Written requests for copies of the SSED should be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., Rm. 1-23, Rockville, MD 20857.

    The SSED is also on display for public viewing at this address during normal business hours.

  4. Via Direct Mailing to the Applicant.

    Out of consideration to the applicant, the PMA Staff will issue a finalized copy of the SSED package to the applicant for their records when considered final by the ODE Director.

  5. Internal Distribution.

    The finalized and dated SSED package will be maintained by the Program Operations Staff. Copies will be distributed to the review division, the IMAGE contractor, and other offices, as necessary.

Effective Date: These procedures are effective immediately.

 Susan Alpert, Ph.D., M.D.