Public Warning and Notification of Recalls; Guidance for Industry and FDA Staff; Availability

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The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry and FDA staff entitled "Public Warning and Notification of Recalls." The guidance establishes guidance for industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notification of recalls under federal regulations. The intent of the guidance is to increase and expedite the appropriate and accurate use of public warnings and public notification and to increase public health protection by better informing the public about violative products being recalled. The guidance clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification.