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Medical Devices / Regulatory Affairs

FDA Releases Final Rule on Appeals of ‘Significant’ CDRH Decisions

July 3, 2019

The FDA issued a final rule for appealing CDRH’s significant decisions about medical devices, including  procedures for submitting a request and timelines for the FDA’s response.

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 and issue 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.

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