Food

Instructions for Submitting Qualified Facility Attestation

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September 2018

The FDA Food Safety Modernization Act (FSMA) establishes requirements for hazard analysis and risk-based preventive controls for facilities that produce food for humans and animals. We have issued two regulations to implement these requirements.

The first regulation is established in 21 CFR part 117 and is entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (published in the Federal Register on September 17, 2015, 80 FR 55907). In the remainder of this guidance we refer to this regulation as “part 117.” Subparts A, B, and F of part 117 include current good manufacturing practice (CGMP) requirements for manufacturing, processing, packing, or holding human food. Subparts A, C, D, E, F, and G of part 117 include requirements for domestic and foreign facilities that are required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d) to conduct a hazard analysis and implement risk-based preventive controls for human food (the human food preventive controls requirements).

The second regulation is established in 21 CFR part 507 and is entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (published in the Federal Register on September 17, 2015, 80 FR 56170). In the remainder of this document we refer to this regulation as “part 507.” For domestic and foreign facilities that are required to register, subparts A, B, and F of part 507 include CGMP requirements and subparts A, C, D, E, and F of part 507 include requirements to conduct a hazard analysis and implement risk-based preventive controls for animal food (the animal food preventive controls requirements).

A facility that meets the definition of a “qualified facility” in part 117 or part 507 is subject to modified requirements in 21 CFR 117.201 or in 21 CFR 507.7 respectively. These modified requirements include the requirement that the facility submit a form to FDA, attesting to its status as a qualified facility. Section II of this document explains how to submit Form FDA 3942a attesting to your facility’s status as a qualified facility under part 117. Section III of this document explains how to submit Form FDA 3942b attesting to your facility’s status as a qualified facility under part 507.

For additional information about how to determine whether your facility meets the definition of “qualified facility” under part 117 or part 507 and about records you would keep to document your determination, see our guidance entitled “Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food: Guidance for Industry” (Ref. 1). 

Download the Instructions for Submitting Your Attestation (PDF: 92KB)

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