US FDA Agent

US FDA agent representation for Medical Devices and IVD Companies

US FDA Agent

The United States Food and Drug Administration (FDA) requires all medical devices and IVD manufacturers located outside of’ the United States to appoint a US Agent. The US  Agent must be either reside in the United States or maintain a physical place of business in the US. Your US Agent serves as a liaison between your company and the FDA.

Obligations

The responsibilities of a US FDA agent:

  • assisting the FDA in communications with your company

  • responding to questions concerning your imported products sold in the US

  • assisting the FDA in scheduling inspections of your facilities.

 

Qserve's US FDA Agent Service Package

Assist FDA in communication with the foreign manufacturer

Assist FDA in scheduling inspections of the foreign manufacturer

Initial registration of the new Establishment

Initial listing of medical devices that will be imported

Annual update of registration and listing records

Importation letter template to facilitate importation

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