U.S. FDA Registration & Labeling Compliance Assistance

 Notes quoted direcly from FDA Website: A business that meets the definition of a “qualified facility” is subject to modified requirements of the preventive controls rules. These modified requirements can be met by submitting a form to FDA, attesting to the business’s status as a qualified facility and attesting that the facility is implementing preventive controls to address hazards associated with its food or is in compliance with non-Federal food safety laws and regulations.

The draft guidance, “Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food),” explains how to determine whether a business meets the definition of “qualified facility” and how to submit the FDA form attesting to its status as a qualified facility. The two draft forms, FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food), once finalized, should be used to submit attestations.

FDA plans to make the final forms available in advance of the 2018 compliance date for human food qualified facilities.

• Draft Guidance for Industry: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)

• Draft Instructions for Submitting Your Attestation: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)