On July 30, 2014, FDA issued a final guidance, “Center for Devices and Radiological Health Appeals Processes:  Questions and Answers About 517A,” which provides an interpretation of key terms for appeals of certain CDRH decisions under section 517A of the Food, Drug, and Cosmetic Act (FDCA), including what constitutes a “significant decision” and a “substantive summary.”  This guidance is a companion to FDA’s 2013 guidance on CDRH Appeals Processes, which describes the processes for seeking an appeal within CDRH as well as the statutory timeframes for the processing of appeals of significant decisions (for our earlier discussion on this guidance, see here).

Section 517A was added to the FDCA in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA).  Section 517A requires that, upon request, FDA must provide a “substantive summary of the scientific and regulatory rationale for any significant decision” of CDRH regarding submission or review of a 510(k) premarket notification, premarket approval application (PMA), humanitarian device exemption (HDE) application, or an investigational device exemption (IDE) application to a person who is seeking to submit, or has submitted, such submission.  In addition, “[a]ny person” may request a supervisory review of such a decision.  Section 517A includes a 30-day deadline for requesting supervisory review of a “significant decision” and also includes deadlines for FDA action.

Other regulatory actions that do not constitute a “significant decision” are still appealable under 21 C.F.R. § 10.75.  However, these appeals are not subject to the statutory deadlines under section 517A for requesting the appeal or for FDA action.  This final guidance introduces new terms, such as referring to a “significant decision” as a “517A decision,” and to all other decisions appealed to CDRH under § 10.75 as “non-517A decisions.”

FDA clarifies that the following types of decisions are considered 517A decisions:

  • 510(k): Not Substantially Equivalent; Substantially Equivalent
  • PMA/HDE: Not Approvable; Approvable; Approval; Denial
  • IDE: Disapproval; Approval
  • Failure to Reach Agreement on a Protocol under Section 520(g)(7) of the FDCA
  • “Clinical Hold” Determinations under Section 520(g)(8) of the FDCA

Unlike the draft guidance, FDA includes clinical hold determinations in this list.

FDA also provides examples of non-517A decisions.  Significantly, FDA includes warning letters as decisions that may be appealed under § 10.75.  Non-517A decisions include:

  • 510(k) Requests for Additional Information
  • PMA Major Deficiency Letter
  • 510(k) and PMA Refuse to Accept Letters
  • Postmarket Surveillance Orders under Section 522 of the FDCA
  • CLIA Waiver Decisions
  • Warning Letters
  • Response Letter to a Request for Information under Section 513(g) of the FDCA

Finally, FDA describes the “substantive summary” that CDRH must provide upon request.  The substantive summary may be the final version of the review memorandum by the lead reviewer or another summary document that includes certain key elements,  including an explanation of the rationale for the regulatory decision.  Notably, the final guidance does not include any timeframes for when FDA will respond to a request for a summary.

FDA explains in the guidance that requests for a substantive summary received from the person who has submitted, or is seeking to submit, the premarket submission, will not be subject to FOIA.  However, should someone other than the owner of the device seek to obtain a “substantive summary” of a 517A decision, the person will need to file a FOIA request.  Trade secret and confidential commercial information would be withheld in FDA’s response to such a FOIA request.