Confidence Beyond Compliance

US Agent / FDA Official Correspondent Services

Are you looking to enter the US medical device market? Do you need an in-country representative? We can help you reach your business goals.

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

The responsibilities of the U.S. 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.

Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

We can serve as your FDA Official Correspondent
An official correspondent is defined as:

  • The person designated by the owner/ operator of an establishment responsible for the annual registration of the establishment and the device listing. The official correspondent also receives correspondence from the FDA involving the owner/operator and any of the firm’s establishments.
  • The official correspondent is responsible for the registration and listing information for each establishment to which he/she is assigned.
  • The official correspondent can:
    • Create new registrations and listings
    • Make changes, updates and cancellations to registrations and listings that have been assigned to them
    • Add their establishment(s) to listings previously entered for the owner/operator
    • View registration and listing information for the establishments which have been created by or assigned to them