Determine whether your facility is required to register with the FDA under the Food Safety Modernization Act (FSMA) and the Bioterrorism Act (21 CFR Part 1, Subpart H). Corporate offices and certain facilities are exempt.
FSMA & Bioterrorism Act Instant Result U.S. & Foreign
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Facility Type
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Activity
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Food Type
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Location
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Result
Question 1
What type of facility do you have?
21 CFR Part 1, Subpart H — FSMA & Bioterrorism Act
Select the option that best describes your facility:
FDA food facility registration applies to facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. Corporate offices and non-food activities do not require registration.
Question 2
Do your food products reach U.S. consumers?
21 USC §350d — Registration of Food Facilities
Are the food products manufactured, processed, packed, or held at this facility offered for sale or distribution in the United States?
Registration is required when food is offered for consumption in the U.S. This includes products sold through importers, distributors, brokers, or directly to retailers or consumers.
Question 3
What type of food does your facility handle?
21 CFR §1.226 — Exemptions
Which best describes the food your facility primarily handles?
Certain food types or operations are exempt from FDA registration even if they otherwise process or hold food for U.S. commerce.
Question 4
Where is your facility located?
21 CFR §1.231 — Foreign Facility Registration
Is your food facility located in the United States or outside the U.S.?
Both U.S. and foreign food facilities that manufacture food for U.S. consumption must register with FDA. Foreign facilities must also designate a U.S. Agent for FDA communications.
Assessment Complete
Your FDA Food Facility Registration Status
For informational purposes only. This tool provides a general assessment based on FDA regulations. Individual circumstances may vary. Always consult a qualified FDA regulatory specialist for advice specific to your situation.