FDA U.S. Agent questions
A U.S. Agent is the U.S.-based contact that foreign facilities must name when registering with FDA for food, medical devices, drugs or cosmetics. FDA uses the agent to reach the facility. Below are the questions foreign manufacturers ask us most, with links to the rules in eCFR and on fda.gov.
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.
Are FDA's own fees included?
No. FDA fees, such as the annual device establishment registration fee, are paid by your company directly to FDA. Our prices cover our service only.
Do you guarantee 510(k) clearance?
No. We prepare 510(k) packages, but FDA decides. Every quote states that there is no clearance guarantee.
Who can't you serve?
We screen every company and its owners against the U.S. Treasury OFAC Specially Designated Nationals list before signing. We may decline or resign an engagement as the agent agreement allows.
Is this legal advice?
No. We provide U.S. Agent and registration support services. For legal questions, consult a licensed attorney.
Sources: 21 CFR 1.227 · 21 CFR 807.40 · 21 CFR 207.69 · FDA cosmetics registration