According the recently published FDA Guidance, 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.
