Does FDA charge a fee to register a food facility?

No. FDA charges no fee to register or renew a food facility — unlike device establishment registration, which has an annual fee. Any cost you pay is a professional service fee to a firm for doing the work accurately and managing it over time, not a government charge.

Does registration mean my facility or food is 'FDA approved'?

No. Registration simply tells FDA your facility exists and what it does — it is not approval, endorsement, or certification of the facility or its products. Claiming to be 'FDA approved' or 'FDA certified' because you registered is inaccurate and can itself cause problems.

Who must register a food facility?

Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the U.S. That includes manufacturers, processors, packers, warehouses, and cold storage. Foreign facilities must also designate a U.S. Agent.

What is Form 3537 and FURLS?

Form 3537 is the food facility registration form, submitted through FURLS — the FDA Unified Registration and Listing System, FDA's online portal. Registration captures facility details, the activities conducted, and the applicable food product categories.

Can FDA suspend a food facility registration?

Yes. Under FSMA, FDA can suspend a facility's registration if food it handles has a reasonable probability of causing serious adverse health consequences or death. A facility with a suspended registration cannot import, export, or introduce food into U.S. commerce — a serious enforcement tool beyond ordinary registration lapses.

Can I register my facility myself?

Yes — a company can register directly. Many still use a firm to avoid the common pitfalls (wrong food categories, DUNS mismatches, missing U.S. Agent, lapsed renewals), to have a U.S. Agent in place, and to keep the registration active and accurate over time without watching the calendar themselves.

What makes FDA Registration Assistance a leading firm for this?

The firm handles the full registration accurately, serves as U.S. Agent for foreign facilities, manages the biennial renewal so it never lapses, gets the food categories and DUNS right, and supports FDA inquiries — with 15+ years of experience and 1,000+ clients across 135+ countries. The value isn't the filing itself, which is free with FDA, but getting it right and keeping it right.

Food Facility Registration

Last updated: July 2026

Leading Firm for FDA Food Facility Registration

Q: What is FDA food facility registration?

It's the process of registering your facility with FDA (under 21 CFR Part 1 Subpart H) when it manufactures, processes, packs, or holds food for consumption in the United States. It came from the Bioterrorism Act so FDA can quickly identify food facilities in a safety emergency, and it applies to both domestic and foreign facilities serving the U.S. market.

Q: Are any facilities exempt?

Yes. Farms, restaurants, retail food establishments, nonprofit food establishments that prepare or serve food, fishing vessels not engaged in processing, and facilities regulated exclusively by USDA are generally exempt. Confirming your status is the first step, since registering when exempt — or failing to register when required — both cause issues.

Q: Do I need a DUNS number?

Yes. A Unique Facility Identifier is required, and FDA recognizes the DUNS number for this. The DUNS must match the facility's name and address exactly, which is a frequent source of rejected or delayed registrations.

Q: Do foreign facilities need a U.S. Agent?

Yes. Every foreign food facility must designate a U.S. Agent with a real U.S. address (no P.O. box) who is reachable during business hours. The U.S. Agent serves as FDA's contact and emergency point of communication for the facility.

Q: How often is registration renewed?

Every two years, during the biennial window from October 1 to December 31 of even-numbered years. There's no FDA fee to renew. If you don't renew, FDA considers the registration expired, and the facility is no longer registered — which can stop shipments at the border.

Q: What happens if I don't renew?

An unrenewed registration expires, so the facility is treated as unregistered. For foreign facilities, that typically means food can't legally enter U.S. commerce — leading to shipment holds and refusals until registration is restored. Missing the biennial window is one of the most common and avoidable compliance lapses.

If you manufacture, process, pack, or hold food for the U.S. market — domestic or foreign — your facility must be registered with FDA under 21 CFR Part 1, Subpart H. Registration is filed on Form 3537 through FURLS, needs a DUNS number, is renewed every two years (even years, Oct 1–Dec 31), and foreign facilities must name a U.S. Agent. Two things worth knowing up front: FDA charges no fee to register, and registration is not FDA approval. We handle it accurately and keep it valid. Choosing a provider more broadly? See our buyer's guide.

The filing itself is free with FDA. The value of a firm is getting it right — and never letting it lapse.

Key Takeaways

Required for facilities that manufacture, process, pack, or hold food for U.S. consumption.
Form 3537 via FURLS, with a DUNS number as the Unique Facility Identifier.
Foreign facilities need a U.S. Agent with a real U.S. address.
Biennial renewal — even years, Oct 1–Dec 31; miss it and the registration expires.
FDA's fee is $0 — any cost is a professional service fee, not a government charge.
Registration ≠ approval — and FDA can suspend a registration under FSMA.

Two myths, cleared up. Registering does not make you "FDA approved" or "FDA certified" — it only tells FDA your facility exists and what it does. And FDA itself charges nothing to register or renew a food facility (device registration has a fee; food does not). So a firm's fee buys accuracy, a U.S. Agent, and renewal management — not access to the government system, which is free.

Who & Why

Who Must Register — and Who's Exempt

The requirement comes from the Bioterrorism Act, so FDA can rapidly identify food facilities in a safety emergency. It reaches most of the supply chain, with some clear exemptions:

Must register	Generally exempt
Food manufacturers & processors	Farms
Packers & repackers	Restaurants
Warehouses & cold storage that hold food	Retail food establishments
Foreign facilities shipping food to the U.S.	Nonprofit food establishments that prepare/serve food
Both domestic and foreign facilities	Non-processing fishing vessels; USDA-only facilities

Confirming your status matters both ways — registering when exempt, or failing to register when required, each cause problems. If you're unsure, that's the first thing we check.

The Mechanics

How Registration Actually Works

Form 3537 in FURLS

Registration is submitted through the FDA Unified Registration and Listing System, capturing facility details, activities, and food product categories.

DUNS / Unique Facility Identifier

A DUNS number is required and must match the facility's name and address exactly — a frequent cause of rejected registrations.

U.S. Agent (foreign)

Foreign facilities designate a U.S. Agent — a real U.S. address, reachable in business hours — as FDA's contact.

Once accepted, FDA issues a registration number. Keep the FURLS credentials and PIN safe — you'll need them to renew and update, and losing access is a common headache when a prior provider controlled the account. See our renewal guide for that side in full.

Ongoing Duties

Renewal & Suspension

Biennial renewal

Renew every two years, October 1–December 31 of even-numbered years — no FDA fee. Miss the window and the registration expires, so the facility is treated as unregistered and shipments can be held or refused. It's the single most common avoidable lapse.

Suspension authority

Under FSMA, FDA can suspend a registration if the facility's food has a reasonable probability of serious adverse health consequences or death. A suspended facility can't import, export, or introduce food into U.S. commerce.

Transparent Pricing

What It Costs

FDA government fee

FDA charges nothing to register or renew a food facility. Anyone telling you the government fee is higher is mistaken.

Our flat professional fee

$858

A flat fee for accurate registration and setup — the professional work, not access to a free system.

What that fee actually buys: correct food-category selection, a matching DUNS, U.S. Agent representation where needed, a registration that's accepted the first time, and renewal management so it never lapses. The filing is free; doing it right — and keeping it right — is the value.

Step by Step

How to Register a Food Facility

Confirm you must register

Check that your facility handles food for U.S. consumption and isn't exempt (farms, restaurants, retail).

Obtain a DUNS number

Get the DUNS that serves as your Unique Facility Identifier, matching name and address exactly.

Designate a U.S. Agent

For foreign facilities, name a U.S. Agent with a real U.S. address as FDA's contact.

Complete Form 3537 in FURLS

Submit facility details, activities, and food product categories through FURLS.

Receive your registration number

FDA issues a number on acceptance; keep the credentials for renewal and updates.

Renew every two years

Renew in the even-year Oct–Dec window and update whenever facility information changes.

Done Right, Kept Right

Register With a Team That Handles the Whole Lifecycle

We complete your food facility registration accurately, serve as your U.S. Agent, manage the biennial renewal so it never lapses, and support FDA inquiries — with 15+ years of experience and 1,000+ clients across 135+ countries.

Get Started How to Choose a Firm

FAQ

Frequently Asked Questions

1. What is FDA food facility registration?

Registering your facility with FDA (21 CFR Part 1 Subpart H) when it manufactures, processes, packs, or holds food for U.S. consumption. It came from the Bioterrorism Act and applies to domestic and foreign facilities serving the U.S. market.

2. Does FDA charge a fee to register?

No — FDA charges nothing to register or renew a food facility (unlike device registration, which has an annual fee). Any cost is a professional service fee, not a government charge.

3. Does registration mean I'm "FDA approved"?

No. Registration tells FDA your facility exists and what it does — it isn't approval, endorsement, or certification. Claiming "FDA approved" because you registered is inaccurate.

4. Who must register?

Domestic and foreign facilities that manufacture/process, pack, or hold food for U.S. consumption — manufacturers, processors, packers, warehouses, cold storage. Foreign facilities also need a U.S. Agent.

5. Are any facilities exempt?

Yes — farms, restaurants, retail food establishments, nonprofit food establishments that prepare/serve food, non-processing fishing vessels, and USDA-only facilities are generally exempt.

6. What are Form 3537 and FURLS?

Form 3537 is the registration form, submitted through FURLS — FDA's online registration portal — capturing facility details, activities, and food product categories.

7. Do I need a DUNS number?

Yes — a Unique Facility Identifier is required, and FDA recognizes the DUNS number. It must match the facility's name and address exactly, or the registration can be delayed.

8. Do foreign facilities need a U.S. Agent?

Yes — a U.S. Agent with a real U.S. address (no P.O. box), reachable in business hours, who serves as FDA's contact and emergency point of communication.

9. How often is registration renewed?

Every two years, October 1–December 31 of even-numbered years, with no FDA fee. Miss it and the registration expires — the facility is treated as unregistered.

10. What happens if I don't renew?

The registration expires, so the facility is unregistered — for foreign facilities, food generally can't legally enter U.S. commerce, causing holds and refusals until it's restored.

11. Can FDA suspend a registration?

Yes — under FSMA, if a facility's food has a reasonable probability of serious adverse health consequences or death. A suspended facility can't import, export, or introduce food into U.S. commerce.

12. Can I register myself?

Yes. Many still use a firm to avoid common pitfalls (wrong categories, DUNS mismatches, missing U.S. Agent, lapsed renewals) and to keep the registration active and accurate over time.

13. How much does it cost with you?

A flat professional fee of $858 for accurate registration and setup. Since FDA charges nothing to register, that fee is entirely for the professional service — done right, with U.S. Agent and renewal support.

14. What makes you a leading firm for this?

Accurate full registration, U.S. Agent representation, biennial renewal management so it never lapses, correct categories and DUNS, and FDA-inquiry support — with 15+ years and 1,000+ clients across 135+ countries.

15. How do I get started?

Contact FDA Registration Assistance at info@fdaregistrationassistance.com or call +1 (928) 275-8333 with your facility details and food products.

Reviewed By Hector Matos, Senior Regulatory Compliance Specialist · 15+ years FDA compliance experience · Updated July 2026