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GUIDANCE DOCUMENT

Public Warning-Notification of Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff February 2019

Final
Docket Number:
FDA-2016-D-3548
Issued by:
Guidance Issuing Office
Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs
Office of Foods and Veterinary Medicine, Center for Veterinary Medicine
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research
Office of Medical Products and Tobacco, Center for Devices and Radiological Health
Office of Medical Products and Tobacco, Center for Tobacco Products

The purpose of this guidance is to assist and provide recommendations to industry and FDA staff regarding the use,content, and circumstances for issuance of public warnings and public notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities. The guidance also discusses what information should be included in a public warning, as well as the parties responsible for issuing it. It represents FDA’s current thinking on public warning and notification of recalls under 21 CFR Part 7.  

This guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including any food, drug, and device intended for human or animal use, any cosmetic and biologic intended for human use, any tobacco product intended for human use, and any item subject to a quarantine regulation under 21 CFR Part 1240. However, it does not apply to radiation-emitting electronic products, which are governed only by 21 CFR Parts 1003 and 1004.


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-2016-D-3548.

Questions?

Contact Point
ORA Office of Strategic Planning and Operational Policy (OSPOP)
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