2018-00918: Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled "Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and FDA Staff." The draft guidance, when finalized, establishes official guidance for industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notification of voluntary recalls under Federal regulations. The intent of the draft guidance is to increase and expedite the appropriate and accurate use of public warnings and public notification, to increase public health protection by better informing the public about violative products being recalled. The draft guidance clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification.
The agency’s own summary, as published.
What this changes
Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.
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