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GUIDANCE DOCUMENT

Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A Guidance for Industry and Food and Drug Administration Staff July 2019

Final
Docket Number:
FDA-2013-D-0501
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-0501.