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FDA and FCC U.S. Agent for foreign manufacturers

The U.S. Agent FDA and the FCC can reach, in your language.

US Agent Desk is a U.S.-based FDA and FCC U.S. Agent service for foreign manufacturers. Foreign facilities registering with FDA for food, devices, drugs or cosmetics must name a U.S. Agent. We serve as that agent, prepare your registration data for your own officer to file, and check FDA's public records for your company every morning.

Check if you need one See prices

Four FDA programs, one agent

Food facility

21 CFR 1.227, 1.230–1.235

Renew every even-numbered year, October 1 to December 31 (21 CFR 1.230(b))

Food facility U.S. Agent requirements →

Medical device establishment

21 CFR 807.40

Renew annually between October 1 and December 31 (21 CFR 807.22)

Medical device establishment U.S. Agent requirements →

Drug establishment

21 CFR 207.69

Renew annually between October 1 and December 31 (21 CFR 207.29)

Drug establishment U.S. Agent requirements →

Cosmetic facility

FD&C Act §607 (MoCRA)

Renew every 2 years

Cosmetic facility U.S. Agent requirements →

FCC U.S. Agent for Service of Process

Making radios, Wi-Fi, Bluetooth or other electronics for the U.S.? Every FCC equipment certification applicant must designate a U.S. agent for service of process (47 CFR 2.911(d)(7)). We serve as that agent for $490 per grantee per year, all FCC IDs included, or $290 as an add-on to any FDA plan. How the FCC agent requirement works.

How it works

  1. Check eligibility. Five questions show which FDA programs apply.
  2. Sign and screen. E-sign the agent agreement; we screen your company against the OFAC SDN list.
  3. Intake in your language. Give us facility, owner, product and registration details.
  4. Your officer files. We prepare a filled checklist naming US Agent Desk as U.S. Agent. Your officer submits it and pays any FDA fee.
  5. We confirm and stay on call. We confirm the designation with FDA and a named person answers FDA contacts.
  6. Watch and renew. Daily checks of import alerts, refusals, warning letters and recalls; renewal packs before each window.

Read the full onboarding process

Published prices

Entry

$990 / year

US Agent and official correspondent for one establishment.

Standard

$1,490 / year

Everything in Entry, plus the paperwork and the daily watch.

Plus

$1,950 / year

For firms with inspections, detentions or new products coming.

Compare plans and add-ons. FDA's own fees are paid by your company directly to FDA.

Common questions

What does an FDA U.S. Agent do?
FDA contacts the U.S. Agent about your registration, routine questions, emergencies and inspection scheduling. For food facilities, FDA treats a communication to the U.S. Agent as a communication to the facility (21 CFR 1.227). The agent must be reachable and pass FDA's messages to you promptly.
Will I get an FDA registration certificate?
No. FDA does not issue registration certificates and does not recognize certificates sold by private companies. We never sell one. After your officer files, your portal shows your registration number and FEI.
Who files the registration with FDA?
Your company's own owner, operator, agent in charge or official correspondent submits the registration in FDA's system and pays any FDA fee. We prepare the data, name US Agent Desk as U.S. Agent, and confirm the designation when FDA asks.
Is this AI, or is there a person?
Both. Software handles intake, document preparation, translation, monitoring and reminders. A named person answers every real FDA contact, with a published response time of 4 business hours and a backup on call.
Can I switch agents mid-year?
Yes. Your officer updates the U.S. Agent in FDA's system and we confirm it. We charge no switching fee. See our guide on how to switch agents.

All questions about FDA U.S. Agents