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Annual U.S. Agent Service for Medical Devices

The FDA requires foreign device establishments to designate an agent located in the United States as its routine point of contact. We serve as your U.S. Agent on an annual basis, handling FDA communication, registration maintenance, and inspection coordination.

RegulatorU.S. FDA
Appointment1-3 business days
Service TermAnnual
Applies ToForeign device establishments
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What this service is

A U.S. Agent is the U.S.-based contact that the FDA requires foreign establishments to designate. The agent bridges the FDA and the establishment for emergencies and routine registration matters and must be reachable during U.S. business hours to respond to FDA inquiries.

The U.S. Agent is appointed by the establishment itself; the FDA does not approve or certify agents. Agent agreements are typically made on an annual basis.

FD&C Act §510(i)21 CFR 807.40

Who needs it

Companies located outside the U.S. that are registering, or already registered, as FDA device establishments
Foreign manufacturers and exporters that need a reliable channel for FDA notices, inquiries, and inspection scheduling
Establishments whose current U.S. Agent arrangement is expiring or that wish to switch agents

Prerequisites and sequence

  • FDA establishment registration is completed or in progress (U.S. Agent details are a required registration field).
  • An official correspondent is identified so the establishment can respond promptly when the agent relays FDA messages.

Who holds regulatory responsibility

Designating a U.S. Agent is a statutory obligation of the foreign establishment, which remains ultimately responsible for substantive responses to FDA inquiries and for compliance remediation. As your agent, we relay FDA communications promptly, support registration account maintenance, and coordinate inspection scheduling.

Materials we need from you

Company name in Chinese and English, and address
Official correspondent name, title, phone, and email
Existing FDA registration number or FEI (if already registered)
Summary of the device portfolio

Process

  1. 01

    Sign the annual U.S. Agent agreement

  2. 02

    Record the agent information in the FDA registration account (or submit it with the initial registration)

  3. 03

    Receive and relay FDA notices and inquiries during the service term

  4. 04

    Support annual registration renewal and account information updates

  5. 05

    If an FDA facility inspection is triggered, assist with scheduling and coordination

Deliverables

Annual U.S. Agent appointment confirmation
Timely relay records of FDA correspondence and notices
Annual registration renewal reminders

Timeline

Agent appointment is typically completed within 1-3 business days; the service term is annual.

Scope

What we provide

  • Serving as the FDA point of contact and relaying official communication
  • Registration account maintenance support
  • Annual renewal reminders and coordination
  • FDA inspection scheduling support

What is not included

  • Substantive technical responses to FDA inquiries (you provide the technical content; we help organize it)
  • Vigilance and adverse-event reporting services (separate agreement required)
  • FDA 483 observation remediation coaching (assessed separately)

What usually follows

FDA Establishment RegistrationDevice Listing

Common pitfalls

Confusing the U.S. Agent with the U.S. importerThe U.S. Agent only performs the FDA communication role and takes no part in importing, selling, or distributing your products. Expecting the agent to handle customs or sales will not work; importer arrangements are made separately.
Assuming the FDA approves or certifies agentsThe agent is appointed by the foreign establishment; the FDA does not approve or recognize agents. Any claim of being an "FDA-certified agent" is unfounded — verify the agent is a lawfully registered U.S. entity.
Choosing an agent that is unresponsive or conflictedFDA inquiries must be answered during U.S. business hours; an unresponsive agent can cause missed FDA deadlines and jeopardize your registration. The agent should also stay neutral and not be tied to importer interests.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

Is the U.S. Agent appointed or endorsed by the FDA?

No. The U.S. Agent is appointed by the foreign establishment; the FDA does not approve or recognize agents. When choosing an agent, confirm it is a lawfully registered U.S. entity with regulatory affairs capability and neutrality — not tied to importer interests.

Is the U.S. Agent the same as the U.S. importer?

No. The U.S. Agent only performs the FDA communication role and takes no part in importing, selling, or distributing your products. Importer arrangements are made separately on the commercial side.

Can we add device listings during the service year?

Yes. New device listings or importer information updates can be handled during the service year; if additional filing work is involved, we will clarify the scope in advance.

Related services

Establishment RegistrationManufacturers, initial importers, specification developers, and other establishments that intend to market medical devices in the U.S. must complete annual establishment registration with the FDA under 21 CFR Part 807 and pay the annual registration fee. We support classification checks, filing, and annual renewal.Device ListingAfter establishment registration, every device marketed in the U.S. must be listed with the FDA, declaring its product code, proprietary name, and premarket submission number. Listing is handled per device, and we complete each filing with you.510(k) SubmissionThe 510(k) is the premarket pathway for most Class II and some Class I devices: demonstrating to the FDA that your device is substantially equivalent to a legally marketed predicate. We support the full project from strategy to clearance.

Disclaimer

The U.S. Agent service is not legal advice and does not represent any FDA endorsement of the establishment. The establishment remains ultimately responsible for its filings and product compliance.