Vaccines, Blood & Biologics

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

Version #2
Effective Date:
June 30, 2016
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  1. Purpose
    The purpose of this document is to describe the policies, procedures, and requirements for Center for Biologics Evaluation and Research (CBER) staff for providing the public with notice of an order approving or denying a Premarket Approval Application (PMA) or Humanitarian Device Exemption (HDE) application. The means by which the public is notified of FDA’s approval or denial of an order are through posting on the FDA Internet domain; public display in the Federal Docket Management System (FDMS); and publishing in the Federal Register (FR) a quarterly announcement of these actions.

     

  2. Scope
    This SOPP applies to all original PMAs and HDEs that have not been withdrawn.

     

  3. Background
    1. Offices in the Center for Biologics Evaluation and Research (CBER) responsible for approving or denying applications must follow 21 CFR 814.44 and 814.45 for PMAs and 21 CFR 814.116 and 814.118 for HDEs.
    2. 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 of (21 CFR 814.45(d)(1)) 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.
      Likewise, CBER is required to post on the Internet a notice of the order approving (21 CFR 814.116(b)) or denying approval of (21 CFR 814.118(b)) an HDE along with a detailed Summary of the Safety and Probable Benefit (SSPB) data, including information about any adverse effects of the device on health.
    3. This information must also be filed with the Division of Dockets Management (DDM), Office of Executive Secretariat (OES), Office of the Commissioner (OC) and be placed on public display in the FDMS.
    4. 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)/814.116(b) and 21 CFR 814.45(d)/814.118(b), respectively).

     

  4. Acronyms and Definitions
    1. Approval or Denial Order - The signed and dated letter sent by FDA to the applicant approving or denying a PMA or HDE.
    2. FDCA - The Federal Food, Drug, and Cosmetic Act.
    3. HDE – A premarket approval application for a class III medical device seeking a humanitarian device exemption from the effectiveness requirements of sections 514 and 515 of the FDCA as authorized by section 520(m)(2) of the FDCA (see 21 CFR 814.3(m). Note that an HDE is a type of PMA.
    4. 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)).
    5. SSED – The Summary of Safety and Effectiveness Data (SSED) is a document mandated by 520(h)(1)(A) of the FDCA. It is to be publicly available upon issuance of an order approving or denying approval of a PMA. (see 21 CFR814.20(b)(3))
    6. SSPB – The Summary of Safety and Probable Benefit (SSPB) is a document mandated by 520(m) of the FDCA. This document is intended to present a reasoned, objective, and balanced critique of the scientific evidence which served as the basis for the approval of the HDE. It provides a reasonable assurance of safety and probable benefit for the device as labeled based on the nonclinical and clinical information described in the HDE. The SSPB is a publicly releasable document that the applicant is required to submit under 21 CFR 814.104(b)(4).

     

  5. Policy
    1. It is CBER policy to complete in a timely manner (usually within 30 days) the redaction, posting, and filing of the PMA or HDE documents, and issuance of the FR notice, as provided below in Sections VI (Responsibilities) and VII (Procedures).
    2. PMA or HDE documents for posting should be written to ensure little or no redaction is necessary prior to posting.

     

  6. Responsibilities
    1. CBER Product Office’s Regulatory Project Manager (RPM):
      1. Assuring the accuracy, timeliness, and quality of information
      2. Assuring compliance with all applicable SOPPs for clearing documents, including obtaining supervisory concurrence
      3. Supplying documents in appropriate formats
        1. Documents going to the Office of Communication, Outreach, and Development (OCOD) are electronic
        2. Documents going to DDM are electronic
      4. Completing all fields and submitting CBER’s Web Posting Request form
      5. Working with the Communication Technology Branch (CTB) as requested to address accessibility, security, and other issues
      6. Reviewing the document or external link periodically for timeliness, appropriateness, and reliability of information, and informing the CTB of any necessary changes
      7. Notifying CBER’s Regulations and Policy Staff (RPS) of the establishment of the docket
    2. Office of Communication, Outreach, and Development (OCOD)/Division of Communication and Consumer Affairs (DCCA)/Communication Technology Branch (CTB):
      1. Reviewing policy, content, and maintenance of the internal and external Web sites, assuring that all Center, FDA, and Department guidelines are met
      2. Submitting documents to Office of Communication, Outreach, and Development/ Division of Disclosure and Oversight Management/ Electronic Disclosure Team (OCOD/DDOM/EDT) for disclosure review, when appropriate
      3. Posting disclosure reviewed and redacted information or documents, while giving priority to time sensitive material
      4. Informing the Point of Contact (POC) when the information or document is posted
    3. OCOD/Division of Disclosure and Oversight Management (DDOM)/ Electronic Disclosure Team (EDT):
      1. Performing disclosure review and redaction, if needed
      2. Providing disclosure reviewed and redacted documents to OCOD/DCCA/CTB for posting
    4. Division of Dockets Management (DDM):
      1. Assigning a docket number
      2. Placing documents on public display
    5. CBER’s Regulations and Policy Staff (RPS):
      1. Conducting periodic reviews of the PMA and HDE action orders posted
      2. Prepare quarterly FR notices of PMA and HDE approvals and denials

     

  7. Procedures
    1. PMA or HDE Approval or Denial Order Issued
      1. Send the appropriate approval or denial documents to CBER’s OCOD using the CBER Web Posting Request Form and request review for disclosure in accordance with 21 CFR 814.9 and other applicable regulations, and posting on the internet [RPM]
        1. Documents are to be submitted at the time of approval or denial in accordance with SOPP 8105: Submitting Documents for the CBER Web Sites using the CBER Web Posting Request Form found on CBER’sIntranet Web Page
        2. The Decision Package may include, but are not limited to:
          1. The signed approval or denial order
          2. SSE data including information about any adverse effects of the device on health
          3. Other supporting documents, e.g., labeling
      2. Send a request for assignment of a Docket Number to the DDM (docketsmanagment@fda.hhs.gov). [RPM]
        1. The request should include, as appropriate:
          1. The PMA/HDE number
          2. Name of the applicant
          3. Trade name of the product
          4. Date of approval or denial of the PMA or HDE
      3. Send the documents to the Electronic Disclosure team for disclosure review. [OCOD/DCCA/CTB]
      4. Review for disclosure and redact (if needed) the Decision Package documents according to Center and Agency policies and procedures. [OCOD/DDOM/EDT]
      5. Notify the Communication Technology Branch when the documents have been redacted and are ready for posting. [OCOD/DDOM/EDT]
      6. Post the Decision Package on FDA's Internet web site according to 21 CFR 814.44 and 814.45 and Center and Agency policies and procedures. [OCOD/DCCA/CTB]
      7. Notify the requesting POC that the documents have been posted. [OCOD/DCCA/CTB]
      8. Review all the documents posted and the content on the website. [RPM]
      9. If a document already posted as part of the Decision Package for posting needs to be replaced in CBER’s EDR: [RPM]
        1. Send a copy of the document with an explanation about which document is being replaced, the reason for the replacement, and whether or not there needs to be a replacement on CBER’s Web page via email to CBER-OCOD-Action Packages for redaction.
        2. The subject line for this email should contain the PMA/HDE number and “replacement document.”
        3. Documents that need to be replaced on CBER’s Web page are those that contain text changes to the document.
      10. Ensure that a single PDF document of the posted documents from the CBER’s Web page is sent to DDM (docketsmanagment@fda.hhs.gov) for public display under the docket number established for the PMA or HDE. [RPM]
        1. The PDF document should include the following documents:
          1. A cover page listing the PMA/HDE number, Assigned Docket #, Name of the Device, and a list of the documents attached to the package.
          2. Dated and signed approval or denial order without concurrence page
          3. Final SSED or SSPB
          4. Other supporting documents, e.g., labeling.
      11. Notify CBER’s Regulations and Policy Staff (RPS) or designee of the docket number established for the PMA/HDE, the PMA/HDE number, trade name of the product, and date of the PMA/HDE approval or denial order. [RPM]
      12. Conduct a quarterly review (i.e., January to March; April to June, etc.) of the PMA and HDE decision orders (approved or denied), and confirm with the Regulatory Information Management Staff (RIMS), Review Management, and/or appropriate CBER Offices, that the PMAs and HDEs that were approved or denied during that quarter were posted on the Internet and in the Docket. [RPS]
      13. Prepare and publish, at the end of each quarterly review, an FR notice listing the PMA and HDE approvals and denials announced in that quarter. [RPS]

     

  8. Appendix
    N/A

     

  9. References
    1. References below are located on CBER's Intranet Web Page
      1. SOPP 8105: Submitting Documents to the CBER Web Sites
    2. Web links to the references below can be found in the list following the History Section
      1. 21 CFR (Relevant Section: Part 814)
      2. FDA Internet domain
      3. Federal Docket Management System (FDMS)
      4. Federal Register

     

  10. History
Written/Revised Approved Approval Date Version Number Comment
RPS/DRS/OCOD Christopher Joneckis, PhD June 13, 2016 2 Updated for new procedures
RPS, DRS R. Yetter Sept 7, 2007 1 First issuance of this SOPP

Page Last Updated: 07/06/2016
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