US FDA Agent

US FDA agent representation for Medical Devices and IVD Companies

 

US FDA AGENT

When is a US FDA Agent required?

Any foreign establishment engaging in the manufacturer, preparation, propagation, compounding, or processing of a device imported into the United States must designate a US Agent for that establishment upon FDA registration. The US Agent must either reside in the US, or maintain a place of business in the US and be available to answer the phone during normal business hours. The US Agent cannot use a PO box or answering service. Qserve can act as a US Agent on behalf of your company.

 

 

Obligations

Responsibilities of the US Agent are limited and include:

  • assisting FDA in communications with the foreign establishment,
  • responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,
  • assisting FDA in scheduling inspections of the foreign establishment and
  • if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

What is an Official Correspondent?

All FDA registered establishments must designate an Official Correspondent to manage their registration and device listing account in the FURLS system (FDA Unified Registration and Listing System).  The person designated as the Official Correspondent is responsible for the annual renewal of the FDA establishment registration and also receives correspondence from FDA involving the owner/operator and any of the firm’s establishments. The Official Correspondent is responsible for the registration and listing information for the establishment.  The Official Correspondent does not have to reside in the United States.  Qserve can act as the Official Correspondent for any registered FDA registered establishment.  Many of Qserve’s clients appoint us as both their Official Correspondent and US Agent.

US FDA AGENT

Qserve's US FDA 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

Annual update of registration and listing records

Initial listing of medical devices that will be imported

Qserve template to facilitate importation

How can we help you? Contact us