US FDA Agent

The United States Food and Drug Administration (FDA) requires all medical device and IVD companies without a presence in the United States to appoint a registered US FDA Agent. The US FDA Agent must be a resident of the United States or maintain a physical place in the US. Your US Agent serves as a liaison between your company and the FDA.

Legal 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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