On May 17, 2013, FDA took significant steps to update its appeals process for medical devices.  First, FDA finalized its guidance on CDRH Appeals Processes, which “describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees.”  Second, FDA issued a new draft guidance on Questions and Answers About 517A, that provides FDA’s interpretation of a “significant decision” under section 517A added by the Food and Drug Administration Safety and Innovation Act (FDASIA).

Background

FDA announced the availability of a draft guidance, Center for Devices and Radiological Health (CDRH) Appeals Processes, on December 28, 2011, that provided detail on how individuals who disagreed with a decision or action taken by CDRH could have it reviewed or reconsidered. 

After FDA issued the draft guidance, Congress enacted FDASIA in July 2012.  As discussed in our client alert, FDASIA added section 517A to the FDCA.  Under this section, 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), PMA, or IDE.  In addition, “[a]ny person” may request a supervisory review of such a decision.  New section 517A included deadlines for requesting supervisory review, providing that a person must submit a request to FDA not later than 30 days after the decision.  The section also includes a deadline for FDA action, requiring that except for cases that are referred to experts outside FDA, the agency must schedule the review not later than 30 days after the request and issue a decision not later than 45 days after the request or 30 days after the meeting or teleconference.

New Guidance Documents

The finalized guidance document on CDRH Appeals Processes largely tracks the 2011 draft guidance.  However, per section 517A, the guidance now includes more specific timelines for appeals.  FDA views the 30 day window as the maximum allowable timeframe for appeals of significant decisions, stating that appeals received after 30 days are not eligible for review under 21 C.F.R. 10.75, the most commonly used form of supervisory review.  The agency notes that “[t]here is no provision in the statute for extensions or waivers, or for partial submissions or ‘placeholders’” for significant decisions.  Although FDA recommends 30 days for appeal of any decision, FDA provides for greater flexibility for non-significant decisions, but clarifies that appeals received after 60 days would be untimely.

The finalized document retains the expectation that sponsors will discuss issues of disagreement  with CDRH before filing an appeal.  The draft guidance provided that “[t]he general expectation is that the stakeholder will follow an orderly progression of interaction with Center employees followed by outreach to relevant members of Management and then engagement with the CDRH Ombudsman, prior to filing a formal request for review or appeal.”  Although some commenters urged FDA to drop this suggestion, in the finalized guidance, FDA again stated that such prior discussion would generally be expected, but that “a stakeholder may file a petition or request for review at any time that is permissible under applicable statutory and regulatory provisions.”

FDA’s accompanying draft guidance on “significant decisions” under section 517A defines “significant decisions” to mean:

  •  finding a 510(k) to be not substantially equivalent (NSE)
  • finding a PMA or Humanitarian Device Exemption Application to either be not approvable or approvable with conditions
  • finding an IDE application to be disapproved
  • failure to reach an agreement regarding a protocol under Section 520(g)(7)

FDA also stated that an approval decision of any of these items may be appealed as a “significant decision.”  Significantly, FDA does not believe that actions earlier in the review process, such as refusals to accept/file, requests for additional information, and deficiency letters, are “significant decisions” subject to section 517A.

For the “substantive summary” that must be provided, FDA states that it “may be the final version of the review memorandum by the lead reviewer or another summary document” that includes (1) the rationale for the regulatory decision; (2) documentation of significant controversies or differences of opinion; and (3) references to relied-upon published literature and consensus standards.  The document would be subject to FOIA requests, but FDA states that generally trade secret and confidential commercial information would be withheld.  The guidance does not state when the summary will be provided to the applicant, but presumably the agency would be obligated to provide the summary in a timely manner, given the 30 day appeal window.

FDA requests comments on the draft guidance by August 15, 2013.