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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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SOPP 8795: Posting and Announcement of Premarket Approval Application Approvals and Denials

Version #1

Effective Date: September 11, 2007


  1. Purpose
  1. The purpose of this document is to describe the policies, procedures, and requirements for Center for Biologics Evaluation and Research (CBER) staff to provide the public with notice of an order approving or denying a premarket approval (PMA) application. The means by which we notify the public are through posting on the FDA Internet domain; public display in the Docket; and publishing in the Federal Register (FR) a quarterly announcement of these actions.
  2. Definitions
  3. PMA

    Any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference therein (see 21 CFR 814.3(e)).

    PMA Approval or Denial Order

    The signed and dated letter sent by FDA to the applicant approving or denying a PMA.

  1. Background
  1. Offices in the Center for Biologics Evaluation and Research (CBER) responsible for approving or denying PMAs must follow 21 CFR 814.44 and 814.45. Under these regulations, CBER is required to post on the Internet a notice of the order approving (21 CFR 814.44(d)(1)) or denying approval (21 CFR 814.45(d)(1)) of a PMA along with a detailed Summary of the Safety and Effectiveness (SSE) data, including information about any adverse effects of the device on health. This information must also be filed with the Division of Dockets Management (DDM), Office of Management/Office of the Commissioner and placed on public display in the Docket.

    At the end of each quarter, CBER is required to publish a list of such approvals and denials in the FR (21 CFR 814.44(d) and 814.45(d), respectively).

  1. Policy
  1. It is CBER policy to complete in a timely manner the redaction, posting, and filing of the PMA documents, and issuance of the FR notice, as provided below in Section 5 – Responsibilities and Procedures.
  2. Responsibilities and Procedures
  3. PMA Approval or Denial Order Issued

    • Request for Review for Disclosure and Posting – After an order is issued to the applicant approving or denying a PMA, the Regulatory Project Manager (RPM) from the responsible CBER Office will ensure that the appropriate documents are sent to CBER's Office of Communication, Training and Manufacturers Assistance (OCTMA), HFM-40, requesting review for disclosure in accordance with 21 CFR 814.9 and other applicable regulations, and posting on the internet in accordance with SOPP 8105: Submitting Documents for the CBER Web Sites.
    • Documents are to be submitted at the time of approval or denial in accordance with SOPP 8106: Submission of Product Approval Information for Dissemination to the Public. Contact the OCTMA Web Manager at 301-827-2000 for specific instructions for submission of electronic documents.
    • The appropriate documents, may include, but are not limited to:
      • the signed approval or denial order,
      • SSE data including information about any adverse effects of the device on health, and
      • other supporting documents, e.g., labeling.
    • Request for Docket Number – At the same time the documents are sent to OCTMA for redacting, the RPM will ensure a request is sent to the DDM (HFA-305) for assignment of a docket number. CBER's Regulations and Policy Staff (RPS), HFM-17, may be contacted for a list of contacts within DDM.
      • The request should include, as appropriate:
        • the PMA number,
        • name of the applicant,
        • trade name of the product, and
        • approval or denial date of the PMA.
    • Posting on the Internet – OCTMA, in consultation with the product office as appropriate, will review for public disclosure and post the documents on the Internet on the Premarket Approval Information - Devices web page, in accordance with 21 CFR 814.44 and 814.45 . After posting, OCTMA will notify the requesting RPM that the documents have been posted.
    • Request for Public Display in the Docket – When notified by CBER's OCTMA that the documents have been posted on the internet, the RPM will ensure that hard copies of the posted redacted documents are printed from the Internet and sent to DDM (HFA-305) for public display under the docket number established for the PMA.
    • Notification of RPS – Upon confirmation of the documents on the Internet, the RPM will notify CBER's Director, Regulations and Policy Staff (RPS). The RPM will provide to RPS the docket number established for the PMA, the PMA number, trade name of the product, and date of the PMA approval or denial order.
    • Preparation of Federal Register Notice – RPS will conduct a quarterly review (i.e., January to March; April to June, etc.) of the PMA action orders posted on the Internet and in the Docket, and confirm with the Office of Management, CBER, the PMA's that were approved or denied during that quarter. RPS will prepare at the end of each calendar year quarter an FR notice listing the PMA approvals and denials announced in that quarter.

     

  1. Effective Date
  1. September 11, 2007
  1. References

21 CFR 814

SOPP 8105: Submitting Documents to the CBER Web Sites

SOPP 8106: Submission of Product Approval Information for Dissemination to the Public

 

  1. History
  1. Written/Revised Approved Approval Date Version Number Comment
    RPS, DRS R. Yetter September 7, 2007 1 First Issuance of this SOPP.