Center for Devices and Radiological Health (CDRH) appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

Center for Devices and Radiological Health (CDRH) appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Devices and Radiological Health, March 27, 2020
Language(s):
English
Format:
Text
Subject(s):
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.
Genre(s):
Technical Report
Abstract:
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.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (5 pages)).
NLM Unique ID:
101772703 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101772703