US Agent Requirements under 21 CFR 807.40

1. Key takeaways

A foreign manufacturing enterprise must designate a United States Agent (U.S. Agent) when submitting its establishment registration information. Under 21 CFR 807.40, the U.S. Agent must reside or maintain a place of business in the United States, and a post office box alone or a telephone answering service alone does not qualify. FDA’s official page makes a further point explicit: the U.S. Agent does not bear responsibility for MDR reporting or for 510(k) submissions. The agent is the communication channel that makes registration possible, while the regulatory duties themselves stay with the manufacturer, and any arrangement that blurs that distinction should be corrected in the service agreement before the registration is filed.

• One establishment is matched with one U.S. Agent, and the agent must confirm agreement in writing within 10 business days of being designated.
• The physical presence requirement is a hard condition: actual residence or a place of business in the United States is required.
• The agent’s role is to assist FDA communication with the foreign establishment, not to take over the manufacturer’s reporting or submission duties.
• Changes to the agent feed into the registration update duty under 21 CFR 807.22(b)(2), within 30 days.
• Import Alert 99-34, last revised 2023-10-18, detains shipments where registration and listing are not both valid, which is the end state of a failed agent arrangement.

2. Legal basis

The authorities and FDA guidance below define who can serve as a U.S. Agent, what the agent must do, and what the agent does not do. The statutory registration trigger in section 510(i)(1) and the import alert that enforces it frame the context in which the designation operates.

3. Expert insights

Insight one: the U.S. Agent is an information channel, not a responsible party.

FDA’s official page lists two obligations the U.S. Agent explicitly does not carry: medical device reporting (MDR) and 510(k) submission. This stands in sharp contrast with the heavier duties imposed on the European Authorised Representative (EC REP) or the United Kingdom Responsible Person (UKRP) in their own jurisdictions. When GRZAN designs a United States licensing structure for Chinese manufacturers, it states clearly to clients that appointing a US Agent does not transfer product compliance responsibility. The distinction matters commercially as well as legally: service agreements sometimes imply broader agent liability, and clients sometimes assume that paying an agent buys compliance coverage. Neither is true, so the contract language, the internal duty matrix, and the training materials should all repeat the same allocation: the agent communicates, the manufacturer complies.

Insight two: the physical presence requirement is a hard condition.

Under 21 CFR 807.40, the agent must reside or have a place of business in the United States. A post office box or a purely telephone-based answering service does not satisfy the condition, which rules out the practice of listing nothing more than a mailbox address. The requirement exists because the agent must be a real, reachable counterpart for FDA communication, capable of receiving notices and passing them to the foreign establishment without delay. When selecting an agent, the manufacturer should therefore verify the actual business address, keep the contact details on file, and re-verify them periodically, since an agent who has quietly closed its office leaves the registration structurally sound on paper but practically broken.

Insight three: one establishment corresponds to one agent, and the agent must confirm agreement in writing within 10 business days.

FDA’s official page states that each foreign establishment must designate one U.S. Agent, and that the agent must respond within 10 business days of designation to confirm agreement. Without that confirmation step, the registration process cannot move forward. This detail is easy to overlook when companies coordinate many sites at once: each establishment needs its own designated agent and its own written confirmation, even where the same service provider represents all of them. Collecting dated evidence of consent for every site at the outset prevents registration filings from stalling mid-process and gives the compliance file a clean record of when and how each designation was accepted. A single tracking sheet listing every establishment, its agent, and the confirmation date is usually enough to keep the whole structure visible at renewal time.

4. Practical recommendations

• Complete the agent’s written consent before registration and obtain dated evidence of it for the compliance file.
• Confirm that the agent has a real place of business within the United States, and keep the address and contact details on record.
• Define the responsibility boundary in the agreement: the agent handles communication and relay, while MDR and 510(k) obligations remain with the manufacturing enterprise.
• When changing agents, update the registration information in step, completing the update within 30 days under 21 CFR 807.22(b)(2).

5. Verification checklist

• □ Every foreign establishment has designated 1 U.S. Agent.
• □ The agent has an actual residence or place of business within the United States, not a post office box.
• □ Written consent issued within 10 business days of designation has been obtained from the agent.
• □ The agreement states that MDR and 510(k) obligations belong to the manufacturing enterprise.
• □ A 30-day update process for agent changes has been established.
• □ The agent can receive FDA notifications and has the capacity to relay them.

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com