Qserve Group | U.S. FDA Agent

U.S. FDA Agent

When is a U.S. FDA Agent required?

The Federal Drug Administration (FDA) requires a U.S. Agent for foreign establishments that manufacture, prepare, or process devices imported into the United States. The US Agent must reside in the United States and be available to answer questions from the FDA during business hours. An Official Correspondent is designated as the individual responsible for maintaining the registration and device listing account during registration. Qserve acts as the U.S. Agent and the Official Correspondent for establishments registered with the FDA.

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US Agent vs. Official Correspondent

For non-US medical device and IVD manufacturers, both a US Agent and an Official Correspondent are required under FDA regulations. While their roles are complementary, they have distinct responsibilities.

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Responsibilities of the US Agent

The US Agent acts as the FDA’s point of contact within the United States. This role includes: Assisting the FDA in communication with the foreign establishment. Responding to questions about the manufacturer’s devices being imported into the US. Assisting the FDA in scheduling inspections of the foreign establishment. The US Agent must be physically located in the United States and listed in the FDA’s FURLS system during registration.

Role of the Official Correspondent

The Official Correspondent is responsible for administrative tasks related to the FDA registration process. This includes: Managing the establishment’s registration and device listing accounts in the FDA’s FURLS system. Handling the annual renewal of establishment registration. Receiving all FDA correspondence related to registration and listing. Unlike the US Agent, the Official Correspondent does not need to be based in the US, but often works closely with the US Agent to maintain compliance.