Initiation of voluntary recalls under 21 CFR Part 7, subpart C: guidance for industry and FDA staff

Initiation of voluntary recalls under 21 CFR Part 7, subpart C: guidance for industry and FDA staff

Collection:
Health Policy and Services Research
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
United States. Food and Drug Administration. Office of Regulatory Affairs, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Center for Food Safety and Applied Nutrition (U.S.), issuing body.
Center for Tobacco Products (United States. Food and Drug Administration), issuing body.
Center for Veterinary Medicine (U.S.), issuing body.
Publication:
Rockville, MD : Office of Regulatory Affairs, March 2022
Language(s):
English
Format:
Text
Subject(s):
Drug Recalls -- legislation & jurisprudence
Medical Device Recalls -- legislation & jurisprudence
Product Recalls and Withdrawals -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
The purpose of this guidance is to clarify FDA’s recommendations for industry and Agency staff regarding timely initiation of voluntary recalls under 21 CFR part 7, subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities. The guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations firms in the distribution chain should consider making to ensure timely responses to a recall communication. Additionally, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by FDA. This guidance applies to voluntary recalls2 of products subject to FDA’s jurisdiction, including any food, drug, and device intended for human or animal use, any cosmetic and biological product intended for human use, any tobacco product intended for human use, and any item subject to a quarantine regulation under 21 CFR part 1240. This guidance applies to devices that are electronic products regulated as radiology devices subject to 21 CFR part 892. It does not apply to electronic products subject to 21 CFR parts 1003 and 1004. FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidance describes the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific statutory or regulatory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (10 pages)).
NLM Unique ID:
9918452087806676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918452087806676