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Contact Info
3335 Tuscarawas Rd
Beaver, PA 15009

+1 855 322 9778

info@qaraconsultinggroup.com

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Copyright © 2019 QA/RA Consulting Group, Inc. ​All Rights Reserved

Contact us today to learn how QA/RA Consulting Group can assist you.

Registered U.S. Agent and FDA Official Correspondent

As an FDA-registered Official Correspondent and U.S. 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.

U.S. Agent

Foreign manufacturers are required to appoint a U.S. 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 nor merely an answering service. They 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.

Contact us today to learn more about how QA/RA Consulting Group can assist you.

FDA Official Correspondent

An Official Correspondent is not required by the FDA, but simplifies communications and registrations. As an FDA-registered entity, we will be responsible for your annual registration and the device listings and will handle most FDA responsibilities.

 

As your Official Correspondent, we will:

  • Handle annual registration and listing your company, including:

    • Creation of new registrations and listings;

    • Cancellation of obsolete registrations and listings;

    • Changes or updates to registration and listing information;

  • Add companies to listings previously entered for the owner/operator;

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

  • Receive pertinent correspondence from the FDA directed to and involving the owner/operator and any of your firm's establishments.

At QA/RA Consulting Group, we strive to make compliance simple. Contact us today about appointing a U.S. Agent and Official Correspondent for one low rate. Additionally, QA/RA Consulting Group can be designated as your Initial Importer during device registration and act as your exclusive FDA representative.