Understanding the Relationship Between FDA Rules, Guidance, and Other Communications

The FDA releases information about the FSMA Produce Safety Rule (PSR) in different forms that range from the codified rule to verbal assistance. Producers are unsure of the legal effect of these forms of communication, when they are required or recommended, and their influence during an inspection or in court. This factsheet outlines these communications and explains whether they are legally binding and when producers must follow them.

This factsheet cross-references:
Using the FDA Technical Assistance Network and FOIA to Access Information about FSMA

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