US FDA Agent

US FDA agent representation for medical devices and IVD companies


US FDA Agent

When is a US FDA Agent required?

A US Agent is required by the Federal Drug Administration (FDA) when a foreign establishment is involved in the manufacture, preparation, or processing of a device that is 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. During the registration process, an Official Correspondent must be designated as the individual responsible for maintaining the registration and device listing account. Qserve can act as both the US Agent and the Official Correspondent for establishments registered with FDA. Local Representation/US Agent 1.jpg?preset=content

Responsibilities of the US Agent

  • Assist FDA in communications with the foreign establishment
  • Respond to questions concerning the foreign establishment's devices that are imported or offered for import into the United States
  • Assist the FDA in scheduling inspections of the foreign establishment Local Representation/US Agent 2.jpg?preset=content

Role of the Official Correspondent

  • Manage registration and device listing account in FURLS system (FDA Unified Registration and Listing System)
  • Responsible for annual renewal of the FDA establishment registration 
  • Receives correspondence from FDA for the registration and listing information for the foreign establishment

Searching for a US Agent?

Have questions regarding FDA’s establishment registration process? Download the brochure to learn more about our US FDA Agent service.  

More information

US FDA Agent

Qserve's US FDA Service Package

Assist FDA in communication with the foreign manufacturer

Initial registration of the new establishment

Annual update of registration and device listing records 

Assist FDA in scheduling inspections of the foreign establishment

Initial listing of medical devices that will be imported

Two hours of regulatory support/advice

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