Is this compliance checker an official FDA tool?

No. FDA does not provide a compliance checker. This tool is an educational checklist to help you prepare and compare providers.

Does the FDA certify U.S. Agents?

No. FDA does not certify or accredit U.S. Agents. Providers should not claim FDA certification or official listing.

How long does it take to get a U.S. Agent set up?

Typically a few business days once the agent receives and confirms the FDA receipt code. Build extra buffer around renewal deadlines.

FDA U.S. Agent Compliance Checker

Answer a few questions to generate a tailored checklist, recommended service tier, and next steps. Built for foreign manufacturers and importers who want to avoid avoidable FDA delays.

Checklist in 2 minutes No email required Actionable next steps

Your Profile

Product type

Number of establishments

Primary manufacturing country

How fast do you need coverage?

What services do you want the agent to handle?

FDA communication forwarding Registration & renewal handling Device listing assistance (if devices) Inspection support / readiness 24/7 emergency contact

Your Compliance Checklist

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Why This Checklist Works

FDA requires foreign establishments to designate a U.S. Agent who is physically located in the United States, available during business hours, and able to forward FDA communications. The FDA does not certify or maintain an official list of U.S. Agents. This checklist focuses on verifiable, non-negotiable requirements and practical risk controls.

Physical U.S. address validation (no PO boxes)
Forwarding SLA and escalation path
Receipt code confirmation process
Documented responsibilities and scope

Related Resources

FDA U.S. Agent List Reality Check U.S. Agent Cost Calculator Change U.S. Agent in FURLS