US Agent Desk Get started

How US Agent Desk works

You check eligibility, pay, and e-sign the agent agreement. We screen your company against U.S. sanctions lists, collect your facility data in your language, and send your officer a filled registration pack naming us as U.S. Agent. Your officer files with FDA, we confirm the designation, and we monitor FDA records for you daily.

  1. Check eligibility

    Answer five questions in the eligibility checker to see which FDA programs apply to your facility. Takes about two minutes.

  2. Choose a plan and pay

    Pay by card through Stripe Checkout. Plans renew yearly; cancel any time.

  3. Sign the agent agreement and sanctions screening

    You e-sign the U.S. Agent agreement. Before we sign, we screen your company and its owners against the U.S. Treasury OFAC Specially Designated Nationals (SDN) list. A possible match pauses onboarding until a person reviews it.

  4. Intake in your language

    A form in your language collects facility, owner, product, DUNS/UFI, FEI and existing registration numbers. We check formats and ask follow-up questions automatically.

  5. Registration data pack

    We send a filled checklist and step-by-step screenshots for your officer, naming US Agent Desk as U.S. Agent. Your officer submits it in FDA's system and pays any FDA fee. We never submit on your behalf without your officer, and we never issue certificates.

  6. We confirm the designation

    When FDA asks the U.S. Agent to confirm, a person on our team confirms and logs it. Your portal shows the status.

  7. Daily FDA watch and renewals

    Every morning at 06:00 Central Time we check FDA recalls, import alerts, import refusals, warning letters and press releases for your company name, FEI and address. Renewal packs go out 30 days before each window opens.

  8. FDA contacts handled by a person

    Any message or call from FDA reaches a named person within minutes, with a translation for you. Our published response time is 4 business hours. We never auto-reply to FDA.

What software does, and what people do

Software handles intake, document preparation, translation, monitoring and reminders. People handle every real FDA contact, every sanctions-screening match and every designation confirmation. Responses to FDA are never sent automatically.

Start with the eligibility checker

Rules: 21 CFR 1.227 · 21 CFR 807.40 · OFAC SDN list