Initiation of Voluntary Recalls; Guidance for Industry and Food and Drug Administration Staff; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry and FDA staff entitled "Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C." The guidance for industry and FDA staff provides guidance on timely initiation of voluntary recalls of FDA-regulated products. It also discusses preparations that firms in a distribution chain should consider making to ensure timely responses to a recall communication. In addition, the guidance 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 This guidance finalizes the draft guidance of the same title issued on April 24, 2019.