Foreign Establishment Registration & US Agents
Foreign manufacturer registration
Foreign manufacturers that export finished medical devices to the USA must register annually with FDA, just like domestic manufacturers. The registration is completed in FURLS and the annual fee applies.
Foreign establishments cannot register directly — they must designate a US Agent who completes the registration on their behalf (or they work with a US-based regulatory representative).
US Agent requirement
Every foreign establishment registered with FDA must designate a US Agent — an individual or entity physically located in the United States who:
- Serves as the primary FDA contact for the foreign establishment
- Must be reachable during US business hours (Eastern Time, generally 9am–5pm)
- Receives FDA communications, regulatory correspondence, and inspection notifications on behalf of the foreign manufacturer
- Is listed in FURLS as the US Agent contact
The US Agent is not the importer — these are separate roles. The US Agent is a regulatory contact; the importer handles the physical importation.
What happens if no US Agent is listed?
Failure to designate a US Agent, or designating an agent who is not reachable, can result in:
- Import alerts
- Refusal of entry for the manufacturer's devices at US ports of entry
- FDA enforcement action