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

GUIDANCE DOCUMENT

• Docket Number: FDA-2016-D-3548
• Issued by: Office of Regulatory Affairs; Center for Veterinary Medicine; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health; 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.

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