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.

Meet Qserve's US Agent, Jennifer Hadfield

Since March of 2016, Jennifer Hadfield has represented Qserve’s global clients as their US Agent and shares a time zone with FDA, ensuring timely communication between parties.

https://www.qservegroup.com/write/Afbeeldingen1/04. 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

https://www.qservegroup.com/write/Afbeeldingen1/04. 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

Qserve template to facilitate importation

Comment pouvons-nous vous aider? Contactez-nous

US FDA Agent

When is a US FDA Agent required?

Responsibilities of the US Agent

Role of the Official Correspondent

Searching for a US Agent?

Qserve's US FDA Service Package

Soyez au courant des dernières actualités de Qserve

Nous partageons l'actualité dans le domaine de la réglementation

Rencontrez les experts de Qserve

Rejoignez notre équipe d'experts en pleine expansion

Suivez-nous sur LinkedIn