Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A

By Effective Medicine  On  In Medical Devices Tagged  

PDF Printer Version DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Document issued on: May 17, 2013

You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.  Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document, contact David S. Buckles at 301-796-5447 or by electronic mail at [email protected].

CDRH Logo

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

Office of the Center Director

Preface

Additional Copies

Additional copies are available from the Internet.  You may also send an e-mail request to [email protected] to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy.  Please use the document number (1821) to identify the guidance you are requesting.

Table of Contents

  1. Introduction
  2. Background
  3. Questions about Section 517A
    • 3.1 What is a “Significant Decision”?
    • 3.2 What is a “substantive summary”?
    • 3.3 Who may request documentation of significant decisions under section 517A, and how does this provision relate to requests under the Freedom of Information Act (FOIA)?

Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A – Draft Guidance for Industry and Food and Drug Administration Staff

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and Food and Drug Administration Staff (2013) (Appeals Guidance). Other terms in section 517A, however, require interpretation.  CDRH has developed this draft guidance document as a companion to the Appeals Guidance to provide proposed interpretations of several provisions of the new law.  When finalized, CDRH intends to include the questions and answers in this draft guidance as an appendix to the Appeals Guidance. 

3. Questions about Section 517A

3.1 What is a “Significant Decision”?

The documentation and review procedures required by section 517A apply only to “significant decisions” concerning submissions under sections 510(k) (Premarket Notification), 515 (Premarket Approval or “PMA”/Humanitarian Device Exemption or “HDE”) or 520(g) (Investigational Device Exemption or “IDE”).  “Significant decision” is not defined.  To ensure the enhanced procedural protections and timelines for actions by both CDRH and device applicants are applied to important decisions at the final stage of review, while permitting additional flexibility in decision-making earlier in the review process, CDRH believes the term should include the following:

  • 510(k): Not Substantially Equivalent; Substantially Equivalent
  • PMA/HDE: Not Approvable; Approvable with Conditions; Approval
  • IDE: Disapproval; Approval
  • Failure to reach agreement on a protocol under section 520(g)(7)

On the other hand, CDRH does not believe that actions earlier in the review process constitute “significant decisions.”  Thus, refusals to accept/file, requests for additional information, and deficiency letters during the review of a premarket submission would not trigger the requirements under section 517A.

CDRH intends that the time frames and procedures specified in section 517A for significant decisions regarding premarket submissions will apply to all requests for supervisory review of such decisions within the Center. For example, a company may request supervisory review by an Office Director of a Not Substantially Equivalent decision issued by a Division Director, and then appeal the Office Director’s decision to the Center Director. FDA intends to apply the procedures and timeframes specified in section 517A to both of these appeals.

3.2 What is a “substantive summary”?

Section 517A of the FDC Act requires the Center to provide, upon request of a person who is seeking to submit or who has submitted a 510(k), PMA, IDE, or HDE, a “substantive summary” of the scientific and regulatory rationale for any significant decision regarding such submission, including documentation of significant controversies or differences of opinion and the resolution thereof. For example, when the submitter of a Premarket Notification under section 510(k) receives a Substantially Equivalent or Not Substantially Equivalent decision from CDRH, the submitter may then request, and CDRH must provide, a substantive summary of the rationale for the decision.  

For decisions that are subject to this provision, the substantive summary may be the final version of the review memorandum by the lead reviewer or another summary document that includes the following elements:

  • An explanation of the rationale for the regulatory decision;
  • Documentation of significant controversies or differences of opinion, i.e., ones the resolution of which had a direct bearing on the regulatory decision; and,
  • References to published literature and consensus standards upon which the decision-maker relied.

3.3 Who may request documentation of significant decisions under section 517A, and how does this provision relate to requests under the Freedom of Information Act (FOIA)?

FDA interprets section 517A(a)(2) to permit persons who have submitted or who are seeking to submit 510(k)s, PMAs, IDEs, or HDEs to request substantive summaries of significant decisions regarding their own device (not the devices of others) without having to file a request under the FOIA.  For example, a sponsor seeking to submit an IDE may request a substantive summary of a decision on a binding protocol agreement under section 520(g)(7) pertaining to a study of its device.    

Since FDA will only be providing these summaries to the owner of any proprietary information contained therein, generally there should not be any need to withhold trade secret or confidential commercial information (CCI) or any other information in the summary.  If someone other than the owner of a device (generally the device sponsor or manufacturer) wishes to obtain a substantive summary of a significant decision regarding such device, that person would need to file a FOIA request.  Generally, trade secret and CCI would have to be withheld in FDA’s response to such a FOIA request but there would be no information exempt from disclosure under 5 U.S.C. § 552(b)(5).



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