Regulatory Services
Foreign device manufacturers registering with FDA must designate a US Agent — a US-based point of contact that FDA communicates with as if communicating directly with the establishment. Without a designated US Agent, registration cannot be completed and imports are blocked. We serve as your US Agent and handle ongoing FDA correspondence with same-business-day forwarding.
Set Up Your US Agent TodayWhat Is a US Agent?
Under 21 CFR 807.40, any foreign establishment that manufactures, prepares, propagates, compounds, or processes a device intended for import into the United States must designate a US Agent. FDA communicates with the US Agent as if communicating directly with the foreign establishment — meaning the agent receives inspection notices, FDA queries about imported devices, and all official agency correspondence on the establishment's behalf.
The US Agent must be physically located in the United States and must be available during normal business hours. A US Agent that cannot be reached — or that fails to forward communications promptly — puts the foreign establishment at risk of import detention, registration lapsing, or enforcement action.
Every foreign manufacturer, contract manufacturer, contract sterilizer, repackager, and relabeler that registers an establishment with FDA must name a US Agent. This requirement is not limited to large manufacturers — it applies to any foreign entity whose device products enter US commerce, regardless of whether those devices require premarket submission. There are no exemptions based on device class, volume, or company size.
If your establishment does not have a US Agent on file, FDA will not process your registration, and your devices cannot legally be imported. When an import shipment arrives without a valid registration — which requires an active US Agent designation — FDA may detain the entire shipment at the port of entry.
The US Agent role under 21 CFR 807.40 includes:
We provide a formal US Agent designation under 21 CFR 807.40 for your foreign establishment. Our service includes:
No. FDA does not require the US Agent to be a regulatory consultant. The US Agent must be physically located in the United States and be reachable during normal business hours. What matters is response reliability — the agent must be able to receive and promptly forward FDA communications to the foreign establishment.
Yes. A foreign establishment may change its designated US Agent at any time by updating the establishment registration in FDA's FURLS system. The change takes effect when the updated registration is submitted. We handle the update as part of our ongoing service.
No. The US Agent's role under 21 CFR 807.40 is to serve as FDA's point of contact — to receive communications and facilitate FDA access to the establishment. The US Agent is not the legal representative of the establishment and does not assume liability for the establishment's compliance with device regulations.
Our US Agent designation service is available as a standalone flat-fee service or bundled with establishment registration and device listing in FURLS. The bundle covers US Agent designation, FURLS registration submission, product code assignment, and listing number confirmation. Annual renewal is included for the first year.
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Foreign manufacturers who skip or delay the US Agent designation face import holds, registration rejection, and delays getting their device into US commerce. We handle the designation, the FURLS submission, and ongoing FDA correspondence — so you can focus on your product.