The U.S. Food and Drug Administration (FDA) recently issued a final guidance document regarding the use, content, and circumstances for the issuance of public warnings and public notifications for firm-initiated or FDA-requested recalls, "Public Warning and Notification of Recalls Under 21 C.F.R. Part 7, Subpart C, Guidance for Industry and FDA Staff" (February 2019).
The guidance applies to food, drugs, devices intended for human or animal use, cosmetics and biologics intended for human use, tobacco products intended for human use, and items subject to a quarantine regulation under 21 CFR Part 1240. Of note, the guidance states that FDA generally recommends public warnings for recalls that are likely to be or have been classified as Class I recalls, unless specific circumstances indicate that the warning would not be beneficial to the public. The agency also recommends and/or issues warnings for some urgent Class II recalls that, while not rising to Class I hazards, still present a serious hazard to health.
Authored by Michael S. Heyl, Jim Johnson, Jodi K. Scott, Edward C. Wilson, Jr., Patricia Shrader and Dennis Gucciardo
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