Issue Date: March 27, 2020
Issued by: Center for Devices and Radiological Health
Topic(s): 510(k), Premarket Approval (PMA), Administrative / Procedural
Status: Final
Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A: Guidance for Industry and Food and Drug Administration Staff
Section 3308 of The Food and Drug Omnibus Reform Act of 2022 (FDORA) enacted as part of the Consolidated Appropriations Act, 2023 (December 29, 2022) amended section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act. This guidance was developed and issued prior to the enactment of FDORA, and certain sections of this guidance may no longer be current as a result. As amended, section 517A(a)(1) no longer includes Breakthrough Device Designation Requests. For more information, please contact the CDRH Ombudsman at CDRHOmbudsman@fda.hhs.gov . This guidance document provides the Center for Devices and Radiological Health (CDRH or the Center) interpretation of key provisions set forth in section 517A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as those provisions pertain to requests for appeals of significant decisions under 21 CFR 10.75, as well as for the timeframes and procedures of regulatory decisions and actions taken by CDRH under 21 CFR 800.75.
Download the Guidance Document
