Your Trusted U.S. Agent for FDA Registrations
Trusted by 1,000+ companies in 135+ countries. This guide explains what a U.S. Agent is and does, who needs one, the legal basis across every FDA category, and how the role differs from an importer, an FSVP agent, and a device Official Correspondent.
What a U.S. Agent Is — and Why It’s Required
A U.S. Agent is a person or company that resides or maintains a place of business in the United States and is physically present and reachable during U.S. business hours. The agent is the FDA’s official point of contact for a foreign establishment: receiving communications, acting as the link for routine and emergency matters, answering questions about your products, and assisting the FDA in scheduling inspections.
The requirement is written into FDA regulation for each category, so a foreign establishment cannot complete its registration without one:
Food · 21 CFR Part 1 Subpart H
Foreign food & beverage facilities must designate a U.S. Agent, who serves as the FDA’s emergency and routine contact for the facility.
Drugs · 21 CFR 207.69
Foreign drug establishments must appoint a U.S. Agent who assists FDA communications, answers product questions, and helps schedule inspections.
Devices · 21 CFR 807.40
Foreign device establishments must designate a U.S. Agent — and a separate Official Correspondent for device-specific correspondence.
Cosmetics · MoCRA
Foreign cosmetic facilities register under MoCRA with a Responsible Person on the label and need a reliable U.S.-based contact for FDA communications.
Not All U.S. Agents Are the Same
The requirement can be satisfied by an agent who simply lists an address — but that’s exactly where foreign companies get burned. The difference shows up the moment the FDA reaches out.
U.S. Agent vs. Importer, FSVP Agent & Official Correspondent
Appoint Us as Your U.S. Agent
1. Send Your Details
Facility name and address, product category (food, drug, device, cosmetic), and any existing FDA registration info.
2. We Designate & Register
We complete or update your registration to name FDA Registration Assistance as your U.S. Agent — typically within 24–48 hours, with no gap if you’re switching agents.
3. We Manage It Year-Round
We actively monitor and handle FDA communications, manage renewals (food is biennial; drug and device are annual), and assist with inspections.
Ready to Appoint Your U.S. Agent?
FDA Registration Assistance serves as your active U.S. Agent across food, drug, medical device, and cosmetic registrations, plus FSVP for food importers — one point of contact for everything. Trusted by 1,000+ companies in 135+ countries with 15+ years of FDA regulatory experience. U.S. Agent service pricing varies by industry — request a quote for your category.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333.
Frequently Asked Questions — FDA U.S. Agent
1. What is a U.S. Agent for FDA registrations?
A U.S. Agent is a person or company located in the U.S. who serves as the official point of contact between the FDA and a foreign establishment. The agent must reside or maintain a place of business in the U.S. and be physically present and reachable during business hours. They receive FDA communications, act as the link for routine and emergency matters, and assist the FDA in scheduling inspections. Appointing one is a legal prerequisite for completing FDA registration as a foreign establishment.
2. Who needs a U.S. Agent?
Any foreign establishment that registers with the FDA: foreign food and beverage facilities, foreign drug manufacturers, foreign medical device manufacturers, and foreign cosmetic facilities distributing in the U.S. If your facility is outside the U.S. and you must register to sell or export FDA-regulated products here, you must designate a U.S. Agent with a physical U.S. address as part of that registration.
3. Is a U.S. Agent legally required?
Yes, for foreign establishments. It’s written into FDA regulation for each area: foreign food facilities under 21 CFR Part 1 Subpart H, foreign drug establishments under 21 CFR 207.69, and foreign device establishments under 21 CFR 807.40. A foreign establishment can’t complete a valid FDA registration without one. Domestic U.S. facilities don’t need a U.S. Agent because they’re already in the United States.
4. What does a U.S. Agent actually do?
It serves as the communications bridge between the FDA and a foreign facility: receiving FDA communications and forwarding them; acting as the contact for routine and emergency matters; responding to questions about the facility’s products; and assisting the FDA in scheduling inspections. If the FDA can’t reach the foreign facility directly, it may provide information to the U.S. Agent, treated as the equivalent of providing it to the facility. An active agent manages all of this so nothing is missed.
5. What is the difference between a U.S. Agent and an importer?
Different roles. A U.S. Agent is the FDA’s contact for a foreign establishment’s registration and handles agency communications. An importer brings the product into the U.S. and handles entry, customs, and (for food) FSVP. One company can be both, but the U.S. Agent relationship is about registration and communications, while the importer relationship is about physical importation and entry compliance.
6. Is the U.S. Agent the same as an agent for service of process?
No. An agent for service of process is a legal designation for receiving lawsuits, often required for state business registration. An FDA U.S. Agent is a regulatory designation specific to the FDA registration system, for receiving FDA communications and assisting with inspections. Completely different purposes — being one doesn’t make a company the other. Foreign companies often need both.
7. What are the requirements to be a U.S. Agent?
A U.S. Agent must reside or maintain a place of business in the U.S. and be physically present here, with a U.S. physical address (not just a P.O. box), reachable during normal U.S. business hours. The agent can’t be a mere answering service or mail drop — they must be able to receive and act on FDA communications. FDA Registration Assistance meets all of these and maintains an active U.S. presence for foreign clients.
8. How many U.S. Agents can a facility have?
Only one U.S. Agent per FDA registration at a time. If a facility holds registrations across multiple categories (e.g., food and drug), each registration needs a designated U.S. Agent, and the same company can serve across them. You can change your agent, but only one can be on record per registration at a time.
9. Do I need a U.S. Agent for FDA food facility registration?
Yes. Foreign food and beverage facilities registering under 21 CFR Part 1 Subpart H must designate a U.S. Agent, who is the FDA’s emergency and routine contact unless another emergency contact is specified. As your U.S. Agent for food, we accept the designation, manage your biennial renewals (food renews every two years, Oct 1–Dec 31 of even-numbered years), and handle FDA communications.
10. How does the U.S. Agent relate to biennial food registration renewal?
For food, the FDA registration renews biennially — every two years, Oct 1–Dec 31 of each even-numbered year. The U.S. Agent, though, is a continuous role: the FDA must be able to reach your agent at any time, not just at renewal. That’s why the U.S. Agent service is maintained year-round and billed annually. We keep your designation active continuously and manage the biennial renewal filing when it comes due.
11. What is an FSVP Agent and how is it different?
Under FSVP (21 CFR Part 1 Subpart L), U.S. food importers must verify foreign suppliers. The FSVP importer must be in the U.S.; if there’s no U.S. owner or consignee at entry, a U.S. agent must be designated as the FSVP importer. That’s a different role from the U.S. Agent on a foreign facility’s registration — it sits on the importer side. We can serve as your FSVP agent and build/maintain the FSVP program.
12. Do foreign drug manufacturers need a U.S. Agent?
Yes. Under 21 CFR 207.69, every foreign drug establishment registering with the FDA must designate a U.S. Agent, who assists FDA communications, answers questions about the establishment’s drug products, and helps schedule inspections. Foreign drug establishments also renew annually and must keep listings current. As your U.S. Agent for drugs, we provide full compliance support, not just a name on file.
13. Do foreign medical device manufacturers need a U.S. Agent?
Yes. Under 21 CFR 807.40, foreign device establishments must designate a U.S. Agent. They must also identify an Official Correspondent — a separate device-specific role for certain regulatory communications and submissions. We can serve as your U.S. Agent for device registration and help coordinate the Official Correspondent function so both roles are covered.
14. Is the U.S. Agent the same as the device Official Correspondent?
No. For devices, the FDA recognizes two distinct foreign-establishment roles. The U.S. Agent is the general contact for communications and inspection scheduling (21 CFR 807.40). The Official Correspondent handles certain regulatory correspondence and submissions. A foreign device company needs both; they can be the same or different parties, and we can set up both correctly.
15. Do foreign cosmetic facilities need a U.S. point of contact under MoCRA?
Under MoCRA, foreign facilities making or processing cosmetics for U.S. distribution must register, and each product is listed by a Responsible Person whose name is on the label. The cosmetic framework centers on the Responsible Person rather than the formal U.S. Agent used for food/drug/device, but foreign cosmetic companies still need a reliable U.S.-based contact for FDA communications. We can serve in that capacity and manage your cosmetic registration and listing.
16. What happens if I don’t have a U.S. Agent or it lapses?
Without a valid U.S. Agent, a foreign establishment can’t complete or maintain its FDA registration — and an invalid registration means products can be detained or refused at the border. If your agent becomes unreachable, resigns, or lapses, the FDA loses its required contact, leading to missed notices and compliance problems that often surface when a shipment is already in transit. An active, responsive agent protects your registration and supply chain.
17. What is the difference between a name-only U.S. Agent and an active one?
A name-only agent just lists an address to satisfy the rule, then does little — FDA communications may sit unanswered and you may not even know the agency reached out. An active agent monitors for FDA communications, forwards and explains them promptly, helps you respond, manages renewals and updates, and assists with inspection scheduling. The difference shows up exactly when it matters: when the FDA contacts your agent about a problem.
18. Can I change my U.S. Agent?
Yes. Change your designated U.S. Agent any time by updating your FDA registration with the new agent’s information; it takes effect once the registration is updated and, where required, the new agent confirms. Many companies switch to us after a previous agent proved unresponsive — we handle the transition and update your registration so there’s no gap in coverage.
19. Does the FDA charge a fee for a U.S. Agent?
The FDA charges no government fee to designate a U.S. Agent — the designation itself is free in the registration system. What you pay is the service fee to the company acting as your agent and providing ongoing communications, monitoring, and compliance support. The exact fee depends on your product category, so contact us for a quote for your category.
20. How much does your U.S. Agent service cost?
U.S. Agent service pricing varies by industry — food, drug, medical device, and cosmetic each have their own pricing, so contact us for a quote for your category. The service covers continuous designation, active monitoring and handling of FDA communications, support for registrations and renewals, and assistance with inspection scheduling throughout the year. The U.S. Agent is a year-round role, which is why it’s maintained and billed annually. FDA charges no government fee for the designation itself.
21. How quickly can you be appointed as my U.S. Agent?
Usually quickly — often within the same timeframe as your registration submission, which is typically completed within 24–48 hours once we have your facility information. If you’re switching from a previous agent, we update your existing registration to name us as your new U.S. Agent so there’s no lapse in coverage. Contact us and we’ll confirm the exact timeline.
22. Will my U.S. Agent handle FDA communications and inspections?
Yes. As your U.S. Agent, we actively receive and manage FDA communications on your behalf, forward and explain them promptly, help you prepare responses, and assist the FDA in scheduling inspections of your facility. That’s the substance of an active service — being reachable and responsive so an FDA communication never goes unanswered and a small question never becomes a detained shipment.
23. Do I need a separate U.S. Agent for each product category?
Each FDA registration must have a designated U.S. Agent, so registrations in multiple categories (e.g., food and drugs) each need the designation. The convenience: one provider can serve across all of them. FDA Registration Assistance acts as a single U.S. Agent partner across food, drug, medical device, cosmetic, and FSVP needs, so you have one point of contact for everything.
24. What industries do you provide U.S. Agent services for?
Every FDA-regulated industry: food and beverage facility registration, FSVP for importers, drug establishment registration, medical device registration, and cosmetic registration under MoCRA. One U.S. Agent partner for all categories means consistent communication and a team that understands how requirements differ.
25. How do I appoint FDA Registration Assistance as my U.S. Agent?
Contact us at info@fdaregistrationassistance.com or +1 (928) 275-8333. Provide your facility name and address, the product category (food, drug, device, or cosmetic), and any existing FDA registration info. We confirm the requirements, complete or update your registration to designate us as your U.S. Agent, and begin actively managing your FDA communications. U.S. Agent service pricing varies by product category — contact us for a quote; FDA charges no government fee for the designation.
