Foreign manufacturers must register their establishments with the FDA to market and distribute their medical devices in the United States. As part of their registration, foreign establishments appoint a US Agent, who communicates with the FDA on its behalf.
The primary purpose of the US Agent is to provide the FDA with a reliable contact located the United States who is legally responsible for being able to reach you. The FDA requires the US Agent to be located in the US, with an US address (and no PO Box), and available to answer the phone during normal business hours.
The responsibilities of a US Agent include:
Assisting you with FDA communication;
Responding to questions concerning your imported products sold in the United States;
Assisting the FDA when scheduling inspections of your facilities; and
Transmitting documentation or communications from the FDA to you when the FDA cannot reach you. FDA communication to the U.S. Agent is considered to be the equivalent of communication with you, the manufacturer.
A US Agent’s work is purely administrative, responsible for routing communication and guaranteeing that the FDA can contact you at any time. Because a US Agent is considered a representative of your company to the FDA, it is crucial to appoint a knowledgeable, reliable, dependable firm to represent your interests.
Some US Agents may not have a sufficient or any regulatory background at all. If a U.S. Agent cannot decipher or explain the FDA communications, make recommendations, or understand FDA actions, you are gambling.
QA/RA is backed by decades of FDA consultation and communications, specializes in medical device regulation and provides a wealth of knowledge and full understanding of FDA operations.
QA/RA can also be designated as your FDA Official Correspondent. In addition to US Agent services, as your Official Correspondent, we will handle annual registrations, device registrations, and be your sole contact for FDA correspondence.