FDA Registration Agent & U.S. Agent
This guide explains what an FDA Registration Agent does, how it differs from the mandatory U.S. Agent, who must designate a U.S. Agent, the agent's responsibilities and legal limits, the qualifications an agent must meet, FURLS confirmation, and renewal cycles across food, drug, device, and cosmetic registrations.
Key Takeaways
- An FDA Registration Agent files and maintains your registration; a U.S. Agent is a legally required domestic point of contact for foreign facilities — related but distinct roles that a single provider can handle together.
- A U.S. Agent is mandatory for foreign facilities: food (21 CFR 1.227), drugs (21 CFR 207.69), devices (21 CFR 807.40), and cosmetics under MoCRA. Domestic U.S. facilities do not need one.
- The agent must be physically present in the U.S. — never a mailbox or answering service — and reachable during business hours. Only one agent per establishment, and the agent must confirm the role in FURLS.
- FDA can treat delivery to your U.S. Agent as delivery to your facility, so a responsive agent is essential to avoid missed deadlines and refused shipments.
- The role is limited to FDA communication — no 510(k)s, no adverse-event reporting, no product liability.
- FDA charges $0 for Food Facility Registration; a complete service that bundles U.S. Agent designation, DUNS Number, and renewal management runs $858.
Who Must Designate a U.S. Agent — by Product Category
The U.S. Agent requirement applies to foreign establishments across every major FDA-regulated category. Each product type is governed by its own part of the Code of Federal Regulations, and a facility that handles more than one category may need a separate registration — each with its own U.S. Agent designation. Domestic U.S. facilities do not need a U.S. Agent, because FDA can reach them directly.
| Product Category | Regulation | U.S. Agent Requirement & Renewal |
|---|---|---|
| Food & Beverage Facilities | 21 CFR 1.227 | Every foreign facility that manufactures, processes, packs, or holds food (including beverages, supplements, and pet food) for U.S. consumption must designate a U.S. Agent to register. Renewed biennially (Oct 1–Dec 31 of even years). |
| Drug Establishments | 21 CFR 207.69 | Foreign drug manufacturers, repackers, and relabelers must designate a U.S. Agent. The agent is specifically required to handle emergency communications from FDA. Renewed annually. |
| Medical Device Establishments | 21 CFR 807.40 | Foreign device manufacturers and specification developers must identify a U.S. Agent in FURLS. The agent must confirm consent (within 10 business days for devices). Renewed annually, with a separate FDA establishment registration user fee. |
| Cosmetic Facilities (MoCRA) | FD&C Act §607 / MoCRA | Foreign cosmetic facilities that manufacture or process cosmetics for U.S. distribution register and provide a U.S. Agent, plus submit product listings. Renewed biennially. |
| Domestic U.S. Facilities | N/A | No U.S. Agent required. FDA can contact and inspect a facility located in the United States directly, so the designation applies only to foreign establishments. |
U.S. Agent Responsibilities — and the Legal Weight Behind Them
The U.S. Agent is FDA's official domestic point of contact for a foreign facility. The role centers on communication — but that communication carries real legal weight, because FDA can treat delivery to your U.S. Agent as delivery to your facility.
Communication Link with FDA
Reviews, disseminates, routes, and responds to all communications from FDA — including emergency communications for drug establishments. The agent is the channel FDA uses when it needs to reach the foreign facility.
Receiving Official Correspondence
If FDA cannot reach the foreign facility directly or expeditiously, it may deliver information or documents to the U.S. Agent — and that delivery is legally equivalent to delivering them to the facility. Any response clock starts when the agent receives the notice.
Assisting with Inspections
Helps FDA schedule inspections of the foreign facility and serves as the coordination point for inspection-related communication between the agency and the facility.
Answering Import Questions
Responds to FDA questions about the facility's products that are imported or offered for import into the United States, helping resolve issues before they escalate to detention or refusal.
What a U.S. Agent Does Not Do
The role is deliberately limited to facilitating FDA communication. A U.S. Agent does not submit 510(k) Premarket Notifications or other regulatory applications; is not responsible for adverse event reporting under the Medical Device Reporting rule (21 CFR Part 803) by virtue of the registration designation; does not take legal ownership of or liability for the product; and is not automatically the importer of record or consignee. Those responsibilities belong to the manufacturer, importer, or separately appointed representatives.
Who Can Serve as a U.S. Agent
FDA sets specific qualifications for who may act as a U.S. Agent. Both an individual and a company can serve, provided they meet these requirements and affirmatively agree to the designation.
Physically Present in the U.S.
Must reside in or maintain a real place of business in the United States and be physically present. It cannot be a mailbox, answering machine, answering service, or any location where the agent is not actually present.
Reachable During Business Hours
Must be available and responsive during normal U.S. business hours so FDA can reach the facility through the agent quickly — especially for urgent safety matters and emergency communications.
One Agent per Establishment
Each foreign establishment may designate only one U.S. Agent. The facility may also, but is not required to, name that agent as its official correspondent.
Must Confirm in FURLS
The designation is not effective until the agent confirms it through FDA's FURLS system. For devices, if the agent denies or does not respond within 10 business days, a new agent must be named.
DUNS Number Required
Registration requires a DUNS Number — the nine-digit identifier FDA uses as the Unique Facility Identifier (UFI) to validate the facility's legal identity and physical location.
Your Importer — or FDA Registration Assistance
A U.S. importer may serve as your U.S. Agent if they qualify and agree. Many facilities prefer an independent, dedicated agent so FDA correspondence is handled promptly and doesn't depend on one commercial relationship.
Registration Services Across Every FDA-Regulated Industry
As your FDA Registration Agent, FDA Registration Assistance prepares and submits your filing, procures your DUNS Number, designates and confirms your U.S. Agent, and manages renewals — across every regulated category:
Food & Beverage
Food Facility Registration for manufacturers, processors, warehouses, beverage companies, supplement producers, and pet food facilities — plus FSVP support for U.S. importers. Biennial renewal managed.
Drugs & Pharma
Drug Establishment Registration and Drug Listing for foreign manufacturers, repackers, and relabelers — with U.S. Agent designation and emergency-communication coverage. Annual renewal managed.
Medical Devices
Medical Device Establishment Registration and Device Listing for foreign manufacturers and specification developers — including FURLS U.S. Agent confirmation. Annual renewal and user-fee guidance.
Cosmetics (MoCRA)
MoCRA Cosmetic Facility Registration and Cosmetic Product Listing for foreign cosmetic facilities — with U.S. Agent designation. Biennial renewal managed.
Drug, medical device, and cosmetic (MoCRA) registration — which may involve separate FDA user fees — is quoted based on scope. Contact us for a quote for your product category. See the full cost breakdown.
How to Appoint an FDA Registration Agent & Designate a U.S. Agent
The path from "we need to sell in the U.S." to an active FDA registration is the same across product categories. Here is the process a registration partner runs on your behalf:
Confirm which FDA registrations apply
Identify your product category — food, drug, medical device, or cosmetic (MoCRA) — to determine which registration and which U.S. Agent regulation governs your facility.
Obtain a DUNS Number
Procure or verify the nine-digit DUNS Number that FDA uses as the Unique Facility Identifier (UFI) to confirm your facility's legal identity and physical location.
Designate your U.S. Agent
For a foreign facility, name a U.S. Agent that is physically present in the United States and reachable during business hours. Each establishment may designate only one agent.
Submit the registration in FURLS
File the facility registration — and the product listing where required — through FDA's FURLS system, including the U.S. Agent information.
Confirm the U.S. Agent designation
The designated agent completes the automated confirmation in FURLS. For device establishments, the agent must respond within 10 business days or a new agent must be named.
Manage renewals
Renew on the correct cycle — biennially for food and cosmetic facilities, annually for drug and device establishments — so the registration never lapses.
Need an FDA Registration Agent or U.S. Agent?
FDA Registration Assistance acts as your U.S. Agent and Registration Agent — completing Food Facility Registration, Drug, Medical Device, and MoCRA Cosmetic registrations, procuring your DUNS Number, confirming your U.S. Agent designation in FURLS, and managing renewals — for companies in 135+ countries.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. 1,000+ clients. 15+ years of FDA regulatory experience.
Frequently Asked Questions — FDA Registration Agent & U.S. Agent
1. What is an FDA Registration Agent?
An FDA Registration Agent is a firm that prepares and submits FDA registrations on your behalf and helps maintain compliance — completing Food, Drug, Device, or MoCRA Cosmetic registration, procuring a DUNS Number, and managing renewals. It is a commercial service role, related to but distinct from the U.S. Agent, which is a formal FDA designation required for foreign facilities.
2. What is a U.S. Agent, and how is it different?
A U.S. Agent is a person or entity physically located in the United States that a foreign facility must designate during registration — FDA's official domestic point of contact. An FDA Registration Agent is the firm that handles the filing. The same firm often does both — acting as your Registration Agent and, for foreign facilities, your designated U.S. Agent.
3. Is a U.S. Agent legally required?
Yes. Every foreign establishment registering an FDA-regulated product must designate a U.S. Agent — under 21 CFR 1.227 (food), 21 CFR 207.69 (drugs), and 21 CFR 807.40 (devices); MoCRA covers foreign cosmetic facilities. Registration cannot be completed without one, and products from an unregistered facility can be refused at U.S. ports.
4. Which foreign facilities must designate a U.S. Agent?
Foreign food and beverage facilities (21 CFR 1.227), foreign drug manufacturers, repackers, and relabelers (21 CFR 207.69), foreign medical device manufacturers and specification developers (21 CFR 807.40), and foreign cosmetic facilities under MoCRA. Domestic U.S. facilities are exempt because FDA can reach them directly.
5. Can a foreign facility register without a U.S. Agent?
No. The U.S. Agent designation is a mandatory part of the registration record for foreign facilities. Without a valid, consenting agent the registration is invalid and products cannot legally enter the United States. If an agent later resigns or goes unresponsive, a replacement must be designated promptly.
6. What are the U.S. Agent's responsibilities?
The agent reviews, routes, and responds to FDA communications (including emergency communications for drugs); answers questions about imported products; assists FDA in scheduling facility inspections; and receives FDA information or documents on the facility's behalf. If FDA cannot reach the facility directly, delivery to the U.S. Agent counts as delivery to the facility.
7. What does a U.S. Agent not do?
The role is limited to FDA communication. Under the device rules, the agent has no responsibility for 510(k) Premarket Notifications or for adverse event reporting under 21 CFR Part 803. The agent does not take legal ownership of or liability for the product and is not automatically the importer of record.
8. Who can serve as a U.S. Agent?
A U.S. Agent must reside in or maintain a real place of business in the United States and be physically present — not a mailbox, answering machine, or answering service — and must be reachable during U.S. business hours. Both an individual and a company can serve if they meet these requirements and agree to the role.
9. Can our U.S. importer be our U.S. Agent?
Yes, if they qualify and agree. Many foreign facilities instead choose an independent, dedicated agent so FDA correspondence and emergency communications are handled promptly and don't depend on a single commercial relationship.
10. How many U.S. Agents can a facility have?
Only one per foreign establishment. A facility that registers in more than one product category carries a separate U.S. Agent designation for each registration. The facility may also, but need not, name the agent as its official correspondent.
11. Does the U.S. Agent have to consent?
Yes. The named agent must affirmatively confirm the designation through FDA's FURLS system. For medical device establishments, if the agent denies consent or does not respond within 10 business days, FDA notifies the facility, which must designate a new agent to keep the registration valid.
12. What if FDA can't reach my foreign facility?
If FDA cannot contact the facility directly or expeditiously, it may deliver information or documents to the U.S. Agent, and that delivery is legally equivalent to delivering them to the facility. A response deadline — for example on a records request or warning letter — starts when the agent receives the notice, so a responsive agent is essential.
13. Do drug establishments need a U.S. Agent?
Yes — foreign drug manufacturers, repackers, and relabelers, under 21 CFR 207.69. The rule specifically requires the agent to handle emergency communications from FDA, so the agent must be reachable when urgent safety issues arise. Drug establishment registration is renewed annually.
14. Do medical device establishments need a U.S. Agent?
Yes. Any foreign establishment manufacturing or processing a device imported into the U.S. must identify a U.S. Agent under 21 CFR 807.40, submitted through FURLS with the agent's confirmed consent. Only one agent per establishment. Device registration is renewed annually and carries a separate FDA establishment registration user fee.
15. Do cosmetic facilities need a U.S. Agent under MoCRA?
Yes. Foreign cosmetic facilities that manufacture or process cosmetics for U.S. distribution register their facilities under MoCRA and provide a U.S. Agent, along with submitting cosmetic product listings. MoCRA facility registration is renewed biennially.
16. Does a domestic U.S. facility need a U.S. Agent?
No. The requirement applies only to foreign establishments. Because FDA can already contact and inspect a facility located in the United States directly, a U.S. Agent is not required for domestic facilities.
17. What is FURLS?
FURLS is the FDA Unified Registration and Listing System — the online portal used to submit, update, and confirm facility registrations and U.S. Agent designations. When a foreign facility names an agent, the agent completes an automated confirmation step in FURLS to accept the role.
18. Do I need a DUNS Number to register?
Yes. FDA requires a DUNS Number — a nine-digit Dun & Bradstreet identifier — as the Unique Facility Identifier (UFI) it uses to validate a facility's legal identity and physical location during registration and renewal. A DUNS Number can be procured as part of a complete registration service.
19. How often must registration be renewed?
It depends on the category: food facility registration renews biennially (Oct 1–Dec 31 of even years); drug establishment registration renews annually; medical device establishment registration renews annually with a user fee; and MoCRA cosmetic facility registration renews biennially. A lapsed registration can interrupt imports, so tracking these deadlines matters.
20. What if my U.S. Agent becomes unresponsive or resigns?
The facility's registration can become invalid and products may be refused at U.S. ports. The facility must promptly designate a replacement agent and update FURLS. Because FDA correspondence delivered to the agent counts as delivery to the facility, an unresponsive agent can cause missed deadlines — a strong reason to choose a dedicated, experienced agent.
21. Can FDA Registration Assistance be our Registration Agent and U.S. Agent?
Yes. FDA Registration Assistance acts as your Registration Agent — preparing and submitting registrations and product listings — and, for foreign facilities, serves as your designated U.S. Agent. The firm supports food, drug, device, and MoCRA cosmetic registrations, procures the DUNS Number, confirms the designation in FURLS, and manages renewals for 1,000+ clients across 135+ countries.
22. How much does it cost?
FDA charges $0 in government fees for Food Facility Registration. FDA Registration Assistance charges $858 for the complete Food Facility Registration service — DUNS Number, registration, U.S. Agent designation, and Biennial Renewal management. Drug, device, and cosmetic registration (which may involve separate FDA user fees) is quoted by scope; contact us for a quote.
23. Can a U.S. Agent be located anywhere in the U.S.?
Yes — anywhere in the United States, as long as the agent is physically present at a real U.S. address and reachable during business hours. The agent doesn't need to be in the same state as the port of entry or importer. What matters is that FDA can reliably reach the agent.
24. How do I appoint an FDA Registration Agent or U.S. Agent?
Contact FDA Registration Assistance at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Provide your product category, facility location, and basic business details. FDA Registration Assistance will confirm which registrations apply, procure your DUNS Number, complete the registration and U.S. Agent designation in FURLS, and manage renewals. Complete Food Facility Registration service: $858.
25. Is FDA registration the same as FDA approval?
No. Registration is not approval, clearance, or endorsement. Registering a facility tells FDA it exists and what it produces — it does not mean FDA evaluated or certified the facility, its products, or its U.S. Agent. Claiming a product is "FDA approved" based on registration alone is a violation, and registration numbers should not be used in marketing to imply approval.
26. Does FDA charge a fee for the U.S. Agent designation?
No. FDA charges no government fee to designate a U.S. Agent, and there is no FDA fee for Food Facility Registration itself. Any cost is the service fee of the firm acting as your agent. Separately, medical device establishment registration carries an annual FDA user fee, and some drug registrations involve FDA fees — but those apply to the registration, not the U.S. Agent designation.
27. U.S. Agent vs. Official Correspondent — what's the difference?
Separate roles. The Official Contact (food) or Official Correspondent (devices) is responsible for a facility's registration record and communications. The U.S. Agent is specifically the domestic point of contact a foreign facility must designate so FDA can reach it in the U.S. A facility may name the same party as both, but is not required to.
28. Can I change my U.S. Agent later?
Yes. Update the designation in FURLS at any time; the new agent must confirm before it takes effect. Registration information must be kept current — for device establishments, changes to designated-agent details must be updated with FDA promptly. A new agent can accept the designation and update your FURLS record for you.
29. How long does registration and U.S. Agent designation take?
With the required information and a valid DUNS Number ready, registration and U.S. Agent designation can often be completed through FURLS within a few business days — sometimes the same day. It takes longer if a DUNS Number must first be obtained, if facility details need correcting, or during high-volume periods like the biennial food renewal window.
30. Does the U.S. Agent file FDA Prior Notice for shipments?
No. FDA Prior Notice is a separate filing required for each food shipment under 21 CFR Part 1 Subpart I, submitted before arrival. It is not part of the U.S. Agent's designated duties — it's typically handled by the importer, filer, or broker, though Prior Notice guidance is often available as a separate service.
