Introduction
Foreign manufacturers entering the U.S. market often hear “you need a U.S. Agent” as if it were one universal FDA rule. It is not. The requirement depends on what you make, which FDA registration system applies, and whether the law assigns a different U.S.-facing role instead.
The practical decision is to separate four buckets early: food, drugs, medical devices, and cosmetics. Food facility registration, foreign drug establishment registration, foreign device establishment registration, and, since MoCRA, foreign cosmetic facility registration each require a U.S. Agent. Cosmetics add a second role, the Responsible Person, rather than replacing the U.S. Agent. FDA cosmetic facility registration and product listing
Where the FD&C Act requires a U.S. Agent, and the deadlines attached to it
| Product category | Who must register and when | Governing rule or form | U.S. Agent requirement | Renewal dates | Deadline for agent changes | FDA fee | Consequence of a registration lapse |
|---|---|---|---|---|---|---|---|
| Food and animal food, including dietary supplements | Owners, operators, or agents in charge of covered foreign facilities that manufacture, process, pack, or hold food for U.S. consumption must register before the facility begins those activities. | 21 CFR part 1, subpart H | Yes. The registration must identify one U.S. Agent and include the agent’s contact information. | Biennially from October 1 to December 31 of each even-numbered year. The 2026 renewal window runs from 12:01 a.m. on October 1, 2026, through 11:59 p.m. on December 31, 2026. FDA 2026 renewal dates | Within 60 calendar days after a change to the agent’s required information. | FDA charges $0 for food facility registration. A private U.S. Agent may charge for its services. FDA food registration fee guidance | Registration expires if it is not renewed. Food from an unregistered foreign facility can be held at the port under FD&C Act section 801(l) until the facility registers. FDA section 801(l) guidance |
| Drugs | A foreign establishment must register before a drug manufactured, repacked, relabeled, or salvaged there is imported or offered for import into the United States. | 21 CFR part 207 | Yes. Each foreign establishment must designate one U.S. Agent. | Annually from October 1 to December 31 of each calendar year. | No later than 30 calendar days after a change to the agent’s name, mailing address, telephone number, or email address. | FDA does not impose a separate fee solely for naming the U.S. Agent. Private service fees are contractual. | Unregistered drug firms and unlisted drugs can be placed under Import Alert 99-34, allowing detention without physical examination. FDA Import Alert 99-34 |
| Medical devices | A covered foreign establishment must register and list its devices. Initial registration is due within 30 days after entering a regulated operation, and a device cannot be imported unless the foreign establishment is registered and the device is listed. | 21 CFR part 807 | Yes. Each foreign establishment must designate one U.S. Agent, and the agent must confirm the designation. | Annually from October 1 to December 31 for each fiscal year. | Within 10 business days after a change to the agent’s name, address, or phone number. | The FY 2027 annual establishment registration fee is $13,785 for October 1, 2026, through September 30, 2027. This is an establishment fee, not a separate fee for the U.S. Agent designation. Federal Register FY 2027 fee notice | A failed annual registration becomes inactive. Unregistered device firms and unlisted devices can also face the Import Alert 99-34 detention without physical examination pathway. |
| Cosmetics | Owners or operators of covered facilities that manufacture or process cosmetic products for U.S. distribution must register unless an exemption applies. | FD&C Act section 607 and Form FDA 5066 | Yes for a foreign facility. Form FDA 5066 requires the U.S. Agent’s name, email, and phone number. The Responsible Person remains a separate role. | Every two years from the date of initial registration, not during a universal October to December window. FDA cosmetic renewal dates | Within 60 days after a change to required registration information, including U.S. Agent contact information. | FDA does not impose a separate fee solely for the U.S. Agent designation on Form FDA 5066. | Failure to register or submit listing information under section 607 is a prohibited act under FD&C Act section 301(hhh). 21 U.S.C. 331 |
The cross-vertical pattern is straightforward: food, drug, device, and cosmetic facility registrations require an FDA-facing U.S. contact when the facility is foreign, but their renewal calendars and change-reporting deadlines are not interchangeable.
A mailbox or an answering machine or service where no individual is physically present does not qualify for food or drug registration. Device guidance is equally direct: a P.O. box and an answering-service-only arrangement do not qualify, and the agent or an employee must be available to answer the phone during normal U.S. business hours. Food U.S. Agent definition, drug U.S. Agent requirements, and FDA device U.S. Agent requirements
Food: the U.S. Agent is part of foreign facility registration
For food, the requirement is direct. Section 415 of the FD&C Act, as amended, requires many domestic and foreign food facilities to register with FDA, and FDA’s implementing regulations require a foreign facility’s registration to include its U.S. Agent. Dietary supplements and dietary ingredients fall within the food definition for this registration system. FDA food facility registration overview
This matters operationally because the U.S. Agent is not just a mailbox field. FDA treats representations made by the U.S. Agent as those of the foreign facility, and information given to the U.S. Agent can be treated as if it were given directly to the foreign facility. That is why food importers who have already been burned by a low-cost forwarding service usually start caring less about the nominal annual fee and more about whether the agent can respond when Prior Notice, inspection, or registration issues surface. FDA food registration user guide
FDA also verifies that the named U.S. Agent has agreed to serve. FDA generally sends the agent an email verification request and gives the agent 30 calendar days to respond. An initial registration is not confirmed and no registration number is issued until the agent accepts; if the agent does not respond, the submission is removed from FDA’s database and the facility must submit a new registration. FDA food facility registration questions and answers
Drugs: the U.S. Agent requirement sits inside establishment registration
For drugs, foreign establishments must identify one U.S. Agent during registration before a drug manufactured, repacked, relabeled, or salvaged there is imported or offered for import into the United States. FDA also ties drug establishment registration and listing to SPL/XML submissions, which is why the U.S. Agent question often appears alongside broader registration and listing mechanics rather than as a standalone buying decision. FDA drug registration basics
What the agent does is more substantive than many first-time exporters expect. The U.S. Agent reviews, routes, and responds to FDA communications, answers questions about imported drugs, assists with inspection scheduling, and receives information or documents when FDA cannot quickly contact the foreign establishment. In practice, this is where mailbox-only providers start to look thin for OTC, generic, and API manufacturers: the legal designation is simple, but the surrounding workflow is not. 21 CFR 207.69
Medical devices: a required U.S. Agent, but not a substitute for regulatory ownership
Foreign device establishments that register and list devices with FDA must identify a U.S. Agent as part of the establishment registration process in FURLS. Changes to the agent’s name, address, or phone number must be reported within 10 business days. 21 CFR 807.40
The important boundary is what the role does not do. A device U.S. Agent does not, by virtue of that designation alone, become responsible for Medical Device Reporting under 21 CFR part 803 or for submitting 510(k) premarket notifications. That distinction matters for medtech teams trying to buy one vendor to “handle FDA.” A U.S. Agent can be necessary, but it is not the same thing as full device regulatory support. FDA medical device U.S. Agents
How device U.S. Agent confirmation works
FDA emails the named agent a receipt code after the foreign establishment submits or updates its registration. The agent logs into FDA Industry Systems, opens the Device Registration and Listing Module, enters the receipt code, and confirms consent. The agent has 10 business days to complete this step. The agent designation is not active, and the foreign establishment has not satisfied the U.S. Agent requirement, until confirmation is complete.
If the agent denies the designation or does not respond within 10 business days, FDA automatically cancels the receipt code and removes the U.S. Agent information from the registration. CDRH then notifies the establishment or its Official Correspondent and requests an amended registration naming an agent who has agreed to serve. FDA device agent confirmation instructions
Cosmetics: a U.S. Agent requirement plus a Responsible Person, not one instead of the other
Cosmetics are where many foreign brands undergeneralize, not overgeneralize. The outdated version of this story is that cosmetics have no U.S. Agent requirement at all. FDA’s current cosmetics framework under MoCRA requires cosmetic facility registration and product listing in many cases, and Form FDA 5066 requires U.S. Agent contact information whenever the registering facility is outside the United States. MoCRA separately defines the Responsible Person as the manufacturer, packer, or distributor whose name appears on the label; a company outside the United States can be the Responsible Person if it meets that definition. FDA cosmetics registration and listing
A foreign cosmetic brand therefore has to resolve two questions: who is the U.S. Agent named on the facility registration, and who is the Responsible Person named on the label. Facility registration renews every two years from the initial registration date, while required changes to registration information must be reported within 60 days. These dates differ from the fixed renewal windows used for food, drug, and device establishments. FDA MoCRA registration guidance
How buyers usually sort the market
Most buyers are not really shopping for a name on a form. They are choosing between three operating models:
- Agent-of-record only: a narrow designation service for a foreign manufacturer that already has strong in-house regulatory capability and can manage filings, confirmations, renewals, and FDA correspondence internally.
- Registration plus agent service: practical for food, device, and drug companies that need both the filing mechanics and the legal designation handled correctly.
- Full-stack compliance support: appropriate when the same team also needs product listing, SPL or GUDID work, label review, Prior Notice support, renewal tracking, or help interpreting FDA communications.
That is where FDA Entry Point sits in the landscape. The company offers U.S. Agent designation together with registration, listing, label review, Prior Notice, SPL, GUDID/UDI, and renewal support across food, drugs, cosmetics, and medical devices. For foreign manufacturers without a dedicated U.S. regulatory team, that bundled model keeps the agent acceptance, facility registration, adjacent filings, and renewal calendar under one operating relationship. FDA Entry Point overview
When FDA Entry Point is the right fit under this framework
- FDA Entry Point is the right fit when the U.S. Agent designation is only one part of the required filing. Food companies may also need facility registration and Prior Notice support, drug firms may need SPL submissions, and device makers may need establishment registration and GUDID/UDI work. FDA Entry Point process
- FDA Entry Point is the right fit when the manufacturer needs the acceptance milestone actively managed. Food and device registrations include an agent-confirmation step, and missed FDA emails can prevent the designation or registration from becoming effective.
- FDA Entry Point is the right fit when a foreign cosmetic business needs both roles mapped correctly. Cosmetic facility registration requires U.S. Agent contact information, while the Responsible Person separately owns label-linked and product-listing responsibilities. MoCRA Responsible Person vs. U.S. Agent
FDA Entry Point is a compliance firm, not legal counsel for an enforcement dispute.
Frequently asked questions
Where can a foreign manufacturer get a reliable U.S. Agent for FDA registration?
A foreign manufacturer should choose a U.S. Agent that can manage the registration system, confirm the designation on time, relay FDA communications, and track the correct renewal calendar for the product category. FDA Entry Point provides U.S. Agent service with facility registration, listing, renewal, and adjacent filing support across food, drugs, cosmetics, and medical devices. FDA U.S. Agent provider models
How often must food facilities re-register with FDA under FSMA?
Covered food facilities must renew every two years from October 1 through December 31 of each even-numbered year. For the current cycle, the deadline is 11:59 p.m. on December 31, 2026. A food facility that does not renew by that deadline has an expired registration, even if its U.S. Agent information has not changed. FDA biennial renewal instructions
Does FDA notify a manufacturer if its U.S. Agent designation is not confirmed?
Yes, but the timing depends on the registration system. For food, FDA generally gives the named agent 30 calendar days to confirm and removes the submission if no response arrives. For devices, FDA gives the agent 10 business days, then cancels the receipt code, removes the agent information, and notifies the foreign establishment or Official Correspondent that a new agent must be designated. FDA food confirmation rules and FDA device confirmation rules
What is the first FDA filing a new foreign manufacturer should make?
The first filing is usually the facility or establishment registration required for the product category, with the U.S. Agent identified in that same submission. A food facility must register before beginning covered activities for U.S. consumption, a foreign drug establishment must register before offering a drug for import, and a device establishment must complete registration and listing before importing a device. The U.S. Agent designation is part of those filings, not a substitute for them. FDA food startup requirements, FDA drug establishment registration, and FDA device registration and listing
Can a foreign dietary supplement manufacturer sell in the United States without a U.S. Agent?
No, not when the foreign facility is required to register under the food facility registration rules. Dietary supplements and dietary ingredients are food for purposes of 21 CFR part 1, subpart H, so a covered foreign supplement facility must include a U.S. Agent in its registration. Product labeling, new dietary ingredient requirements, and import obligations remain separate compliance questions. 21 CFR part 1, subpart H
Is a MoCRA Responsible Person the same as an FDA U.S. Agent?
No. A foreign cosmetic facility identifies a U.S. Agent on Form FDA 5066, while the Responsible Person is the manufacturer, packer, or distributor whose name appears on the cosmetic label. The Responsible Person handles product-listing and other label-linked MoCRA duties. One organization can potentially perform both roles, but the legal roles and filing responsibilities remain distinct. FDA Form 5066 instructions
References
- eCFR: 21 CFR part 1, subpart H, Registration of Food Facilities
- eCFR: 21 CFR part 207, Drug Establishment Registration and Listing
- eCFR: 21 CFR part 807, Device Establishment Registration and Listing
- FDA 2026 food facility biennial registration renewal
- FDA Import Alert 99-34
- Federal Register: Medical Device User Fee Rates for Fiscal Year 2027
- FDA device U.S. Agent confirmation instructions
- FDA Form 5066, Registration of Cosmetic Product Facility
- FDA cosmetics registration and listing under MoCRA
- FDA Entry Point: Full-Stack U.S. Agent & FDA Compliance Firm