CDRH Unveils Appeals Guidance Document
The U.S. Food and Drug Administration has released a highly anticipated final guidance document designed to help medical device manufacturers that are seeking an appeal of decisions made by reviewers at the Center for Devices and Radiological Health (CDRH).
The guidance, issued May 17, provides general information about three ways to seek a reconsideration of a CDRH reviewer’s decision: petitions, hearings, and requests for supervisory review. The latter process, which is the most commonly used appeals mechanism, was more flushed out in draft guidance issued in December 2011. Through this procedure, a CDRH supervisor reviews an adverse decision, such as the denial of a premarket approval application, following a device manufacturer’s request.
Although the draft guidance provided some clarification on the supervisory review procedure, Congress added some complexity with its passage of the Food and Drug Administration Safety and Innovation Act last summer. The act included a section adding requirements within Section 517A of the Federal Food, Drug, and Cosmetic (FD&C) Act on the supervisory appeals process that compel CDRH to provide a “substantive summary” of the scientific and regulatory rationale for any “significant decision” under appeal.
As a result of the new requirements, CDRH has sought to define “significant decision” and “substantive summary” in an accompanying draft question and answer document that, once finalized, will become an appendix to the final guidance.
The draft Q&A guide defines “significant decisions” to include the following:
- Not substantially equivalent or substantially equivalent decisions on 510(k) submissions
- Not approvable, approvable with conditions, or approval decision for premarket approval applications or humanitarian device exemptions
- Approval or disapproval of an investigational device exemption
- Failure to reach agreement on a protocol under section 520(g)(7) of the FD&C Act
Actions earlier in the review process, including refusals to file, would not fall under the definition of “significant decision,” the Q&A document notes.
In defining “substantive summary,” CDRH says it may be the final version of a lead reviewer’s final memorandum or a document that includes the following:
- An explanation of the rationale for the decision
- Documentation of significant controversies or differences of opinion
- References in published and consensus standards upon which the decision maker relied
To access the final guidance, please click here. The draft Q&A document, please click here.
Posted: 05.22.13