If you manufacture a medical device outside the United States and want to sell it here, FDA requires you to designate a US Agent. It is a small, mandatory piece of market access that is easy to get wrong.
Who needs one
Any foreign establishment that manufactures, prepares, propagates, compounds, or processes a device imported (or offered for import) into the United States must register with FDA and designate a single US Agent. The agent must reside in, or maintain a place of business in, the United States.
What a US Agent actually does
The US Agent is FDA’s point of contact for the foreign establishment. Responsibilities include:
- Assisting FDA in communications with the foreign establishment
- Answering questions about the establishment’s devices that are imported into the US
- Helping FDA schedule inspections of the foreign establishment
- Receiving information or documents from FDA on the establishment’s behalf if FDA cannot reach it directly
The US Agent is a communication liaison; it does not assume the manufacturer’s regulatory responsibility for the device.
How it differs from related roles
- US Agent: required for foreign establishments; FDA’s liaison to that establishment.
- Official Correspondent: the contact responsible for an establishment’s registration and listing duties (a different, registration-focused role).
- Initial Importer: the US party that first receives the imported device for resale; an importer is not automatically your US Agent.
Confusing these roles, or naming an agent who is not genuinely reachable, can stall imports and inspections.
Getting it right
Your US Agent should be responsive, understand FDA communications, and be ready when an inspection or question lands. A non-responsive agent is a real regulatory risk.
Sequence Group provides FDA US Agent representation for non-US medical-device manufacturers, backed by 20+ years of FDA regulatory experience. If you need a US Agent, get in touch.