The FDA issued a final rule on appealing CDRH’s significant decisions about medical devices, including procedures for submitting requests and timelines for the agency’s responses.
The rule, which goes into effect Aug. 1, covers requests for review of significant CDRH decisions relating 510(k) premarket notifications, premarket approval applications and humanitarian device exemptions. It also covers requests for breakthrough device designations, or investigational device exemptions.
Under the final rule, a request for review must be submitted no later than 30 days after the decision. The FDA must schedule a meeting within 30 days of a request and make a decision no later than 30 days after that. If there’s no in-person or teleconference meeting, the FDA must issue a decision within 45 days of the request.
The rule also establishes procedures for requesting supervisory review of other CDRH decisions not covered under the FDA Safety and Innovation Act and the 21st Century Cures Act.
The agency said the final rule “provides transparency and clarity for internal and external stakeholders: and gives requesters “new predictability through binding deadlines for FDA action on a request for supervisory review.”
Read the final rule here: www.fdanews.com/07-05-19-FinalRule.pdf. — Gienna Shaw