Starting today, the FDA is inviting comments on a draft guidance document for determining whether your business meets “qualified facility” definitions under FSMA’s Preventive Controls for Human Food.
When finalized, the guidance will explain how to determine your qualification status and how to submit the form (FDA 3942a) attesting your status to the FDA. Guidance of this sort is a nonbinding representation of the FDA’s current thinking on a given topic.
Electronic comments may be submitted at http://www.regulations.gov. Written comments may be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.