How Can We Assist You?

Representing Foreign Manufacturers from Registration to Distribution

US Agent and FDA Official Correspondent

As an FDA Official Correspondent and FDA US Agent, QA/RA Consulting Group can assist with your FDA registration. Establishment registration utilizing the FDA Unified Registration and Listing System (FURLS) is the first step in reaching U.S. markets with your medical device.

FDA US Agent

Foreign manufacturers are required to appoint a US Agent during Establishment Registration. This registration requirement applies to the following categories of foreign establishments:​

  • Primary Manufacturers

  • Contract Manufacturers and Remanufacturers

  • Contract Sterilizers

  • Foreign Exporter of devices located in a foreign country

  • Specification Developers/Reprocessors of single use devices

A U.S. Agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. Agent cannot use a post office box as an address or an answering service. The U.S. Agent must be available to answer the phone or have an employee available to answer the phone during normal business hours.

As your U.S. Agent, we will:

  • assist you with communications with the FDA;

  • respond to FDA questions concerning your devices that are imported or offered for import into the United States;

  • assist you in scheduling FDA inspections; and

  • if the FDA is unable to contact you directly or expeditiously, we will receive the information or documents on your behalf and forward them to you.

FDA Official Correspondent

An Official Correspondent simplifies communications and registrations with the FDA. As an FDA-registered entity, QA/RA Consulting Group will be responsible for your annual registration and the device listings and will handle most registration-related FDA responsibilities.

As your Official Correspondent, we will: 

  • Handle annual registration and listing, including:

    • Creating new registrations and listings;​

    • Canceling obsolete registrations and listings; and

    • Changing/updating registration and listing information

  • ​Maintain and a current list of officers and directors ​and submit it to the FDA upon request; and

  • Receive pertinent correspondence from the FDA on your behalf.​

U.S. Agent / Official Correspondent Inquiry

Thanks! Check your inbox for verification email.

 

​QA/RA strives to make compliance simple. Partner with a trusted FDA compliance expert to handle your FDA obligations. We also provide initial importer services, learn more here.

Learn More About QA/RA

The Latest from the QA/RA's Blog