The FDA today released draft guidance clarifying existing recommendations for how medical device manufacturers can appeal the federal watchdog agency’s decisions on marketing applications.
The draft guidance, which the FDA is asking industry to comment on over the next 90 days, pertains to requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by the FDA’s Center for Devices & Radiological Health.
The draft defines what a "significant decision" is, something that was previously not specified. Significant decisions are now restricted to 510(k): not substantially equivalent or substantially equivalent; PMA/HDE: not approvable or approvable with conditions; approval IDE: disapproval or approval; or failure to reach agreement on a protocol.
The agency does not believe that actions earlier in the review process constitute "significant decisions." Thus, the FDA is not required to respond to appeals to any of the following: Refusals to accept/file, requests for additional information, or deficiency letters during the review of a premarket submission.
The FD&C Act requires the FDA 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 the submission, including documentation of significant controversies or differences of opinion and the resolution thereof, the draft guidance stated.
For example, anyone who submits a 510(k) receives either 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.
According to the draft guidance, the substantive summary may be the final version of the review memorandum by the lead reviewer or another summary document that includes the following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.
In addition, the draft guidance spells out timeframes for the appeals process. Device marketing applicants are entitled to request a supervisory review of the significant decision made with regard to their device application within 30 days of the decision, in which they must indicate whether they want an in-person meeting or a teleconference review, according to the federal watchdog.
The FDA then has 30 days to respond to the request, and has 45 days after the initial request is made to issue a decision. In cases where an in-person meeting or teleconference has been requested, the agency has up to 30 days after such meeting or teleconference to issue a decision.
The draft guidance noted that these timeframes do not apply in cases that are referred to experts outside of the FDA.
Also, the review may be conducted at the next supervisory level or higher above the individual who made the significant decision, the FDA stated.
Additionally, the draft guidance clarifies that the FDA will only provide these summaries to the owner of any proprietary information, so there should be no need to withhold trade secret or confidential commercial information or any other information in the summary.
Anyone other than the device owner (generally the device sponsor or manufacturer) would need to file a FOIA request to obtain an executive summary of a significant decision. The FDA clarifies that it would withhold trade secret and confidential commercial information, but is not required to withhold any other information.
The agency noted that it developed this draft guidance as a companion to its current appeals guidance. When finalized, the agency intends to include the questions and answers in this draft guidance as an appendix to the appeals guidance.