FDA Releases Final Guidance on Voluntary Recalls

The U.S. Food and Drug Administration (FDA) has issued a final guidance to help medical device manufacturers and others facilitate the execution of voluntary product recalls.

The guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” details a step-by-step process to help companies in the product distribution chain be “recall ready.” The guidance includes helpful details for preparing to facilitate a timely initiation of a voluntary product recall, as well as recommended procedures for initiating a recall and related activities. The guidance also sets forth specific indicators to help companies determine when issuing a voluntary product recall might be appropriate.

The FDA guidance applies to voluntary recalls of most products subject to FDA jurisdiction, including “any food, drug, and device intended for human or animal use.” However, the guidance expressly excludes electronic products subject to 21 CFR parts 1003 and 1004.

FDA guidance documents are intended only to provide manufacturers with insight into the agency’s current thinking and do not establish legally enforceable responsibilities.

Read the FDA’s final guidance on voluntary recalls.

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