Center for Devices and Radiological Health Appeals Processes

OMB 0910-0738

OMB 0910-0738

This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH or the Center) employees. The Food and Drug Administration (FDA) is seeking approval for the new reporting burden associated with requests for additional review of decisions and actions by CDRH employees as described in this guidance. Individuals outside of FDA who disagree with a decision or action taken by CDRH employees and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including: requests for supervisory review of an action, petitions, and hearings. Of these, by far the most commonly used is a request for supervisory review under 21 CFR 10.75 (a "10.75 appeal"). Section 517A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 603 of the FDA Safety and Innovation Act of 2012, includes new requirements pertaining to the process and timelines for 10.75 appeals of "significant decisions" regarding 510(k) premarket notifications, applications for premarket approvals (PMAs), and applications for investigational device exemptions (IDEs). In this guidance document, the term "significant decision" will refer to significant decisions pertaining to these submissions.

The latest form for Center for Devices and Radiological Health Appeals Processes expires 2022-08-31 and can be found here.

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