FDA US Agent: Requirements, Duties, and Appointment

If your facility is located outside the United States and makes, processes, packs, or holds food, drugs, or medical devices for the U.S. market, you must designate an FDA U.S. agent before you can register with the agency. The agent is a person or business inside the United States who serves as the FDA’s point of contact for your facility: they handle communications, help coordinate inspections, and can accept official documents on your behalf. The rules vary slightly by product category, but the core requirement is the same.

Who Has to Appoint a US Agent

Federal law requires any facility located outside the United States that manufactures, processes, packs, or holds FDA-regulated products for U.S. consumption to register with the agency and designate a single U.S. agent.¹ The requirement spans three product categories: food (including dietary supplements and animal feed), human and animal drugs (including biologics), and medical devices.

Each product type is governed by its own regulation. Food facilities register under 21 CFR Part 1, Subpart H.² Drug establishments register under 21 CFR Part 207.³ Medical device establishments register under 21 CFR Part 807.⁴ If your facility handles products in more than one category, you may need separate registrations, each with its own agent designation.

Facilities located inside the United States do not need a U.S. agent. They already fall under direct FDA jurisdiction, so the agent requirement applies only to foreign establishments.

What the Agent Must Be

The qualifications are consistent across food, drug, and device registrations. Your U.S. agent must be a person or business entity that resides in or maintains a place of business in the United States.⁵ The agent needs a real physical address. A P.O. box does not qualify, and neither does an answering machine or answering service.³

The agent must also be available to answer phone calls during normal U.S. business hours, either personally or through an employee.⁶ This matters more than it sounds. If the FDA calls with a question about a shipment sitting at the port and nobody picks up, the goods stay put. Each foreign facility can name only one U.S. agent at a time.

The FDA does not require any license or certification to serve as an agent. It can be an employee who lives in the States, a trusted business partner, or a commercial regulatory service. Many foreign facilities hire professional agent companies because they already understand FDA processes and keep staffed offices during business hours. Fees for these services typically run from a few hundred to several thousand dollars a year, with device agents at the higher end because device regulation is more complex. The FDA itself does not charge for the agent designation.

What the Agent Does

The FDA describes the U.S. agent’s responsibilities as “limited,” and they come down to three functions.⁶

Helping the FDA communicate with the foreign facility, including reviewing, routing, and responding to correspondence.
Responding to FDA questions about products that have been imported or offered for import.
Helping the FDA arrange inspections of the foreign facility.

One further function gives the role real legal weight. If the FDA cannot reach the foreign facility directly or quickly enough, the agency can deliver information or documents to the U.S. agent instead, and that delivery counts as delivery to the foreign facility itself.³ If the FDA sends a warning letter or a records request to your agent, the response clock starts when the agent receives it. You cannot claim you never got the notice because it went to someone in a different country.

For drug establishments, the regulation adds that the agent must handle “emergency communications” from the FDA.³ In practice, that means being reachable when safety concerns arise, such as suspected contamination or a recall situation, and relaying information between the FDA and your facility quickly.

What the Agent Is Not Responsible For

The agent is not your regulatory compliance department. For medical device establishments, the FDA explicitly states that the U.S. agent has no responsibility for reporting adverse events under the Medical Device Reporting regulation or for submitting 510(k) premarket notifications.⁶ Those obligations fall on the manufacturer. The same principle carries across product types: your agent handles communication logistics with the FDA, not your underlying compliance work.

US Agent Versus Official Correspondent

The FDA registration process asks you to name both a U.S. agent and an “official correspondent,” and many first-time registrants mix them up. The official correspondent is the primary contact person listed on the registration who receives routine correspondence and can update the facility’s registration information. You can designate your U.S. agent to also serve as the official correspondent, but you are not required to.⁶ Smaller foreign companies often combine both roles for simplicity, while larger organizations keep them separate so that internal staff handle day-to-day registration management while a third-party agent handles FDA communications.

How to Appoint One

Before starting the electronic registration, gather the following information about your chosen agent:

Full legal name of the individual or entity.
Physical street address, including suite or unit number, city, state, and ZIP code. No P.O. boxes.
Direct phone number where the agent or an employee can be reached during U.S. business hours.
Monitored email address, because the FDA will send a verification email there.

You enter this information through the FDA Industry Systems (FIS) portal.⁷ The specific module depends on your product: food facilities use the Food Facility Registration Module, drug establishments use the Drug Registration and Listing System, and device establishments use the Unified Registration and Listing System. Check every field. A typo in the agent’s email address will derail the entire verification process.

The Confirmation Step

Once you submit the agent’s details, the system sends an automated verification email to the agent’s address. The email contains a receipt code the agent must use to confirm they accept the role.⁸ The agent logs into the FIS portal, opens the “Confirm U.S. Agent Notification” section, enters the receipt code, selects “Yes,” and submits.

The agent has 10 business days to complete this confirmation. If nothing comes back in that window, the system cancels the receipt code and removes the agent from the registration.⁸ The official correspondent or owner-operator is notified and has to designate a new agent to finish the registration.⁶ Your registration is not active until the confirmation goes through, so make sure your agent knows to expect the email.

Changing Your US Agent

If your U.S. agent steps down, becomes unreachable, or you want to switch providers, update the agent information through the FIS portal by editing the U.S. agent fields on your existing registration. The new agent goes through the same email verification process. For medical device establishments, the regulation requires you to report any change to the agent’s name, address, or phone number within 10 business days.⁴ Letting this slip is a common compliance gap. If the FDA tries to contact your listed agent and the information is outdated, that creates the same problem as having no agent at all.

Keeping the Designation Active

Appointing an agent is not a one-time task. Your registration has to be renewed on a schedule that depends on the product type, and the agent designation renews with it.

Food facilities: renew every two years during October 1 through December 31 of each even-numbered year. Miss the deadline and the registration expires and is removed from your account.⁹
Drug establishments: renew annually between October 1 and December 31. Registrations submitted in that window stay active through the end of the following calendar year.¹⁰
Device establishments: renew annually.¹¹

An expired registration means your products can be stopped at the border. Set calendar reminders well before October 1 each year.

What Happens Without a Valid Agent

For food facilities, the consequences are written directly into federal law. Section 801(l) of the Federal Food, Drug, and Cosmetic Act provides that food arriving from a foreign facility without a valid registration must be held at the port of entry and cannot be delivered to the importer until the facility completes its registration.¹² You cannot complete registration without a U.S. agent, so a missing agent effectively blocks your food shipments.

For drug and device establishments, the FDA can refuse entry of products from unregistered foreign facilities and may take enforcement action. Facilities that register late or let registrations lapse sometimes find that their next inspection gets prioritized, and not in a way they would prefer.

1
Office of the Law Revision Counsel. 21 USC 350d – Registration of Food Facilities
2
eCFR. 21 CFR 1.225 – Who Must Register
3
eCFR. 21 CFR 207.69 – What Are the Requirements for an Official Contact and a United States Agent
4
eCFR. 21 CFR 807.40 – Registration Requirements for Foreign Establishments
5
eCFR. 21 CFR 1.227 – What Definitions Apply to This Subpart
6
U.S. Food and Drug Administration. US Agents
7
U.S. Food and Drug Administration. Online Registration of Food Facilities
8
FDA Industry Systems. Confirm US Agent Notification Receipt
9
U.S. Food and Drug Administration. Food Facility Registration User Guide – Biennial Registration Renewal
10
U.S. Food and Drug Administration. Drug Establishments Current Registration Site
11
U.S. Food and Drug Administration. Device Registration and Listing
12
U.S. Food and Drug Administration. Compliance Policy Guide Section 100.250 – Food Facility Registration