US FDA Official Correspondent for Medical Device Companies

ANSWERED ON THIS PAGE:

• What is a US FDA Official Correspondent (OC)?
• How is an Official Correspondent different from a US Agent?
• Are we required to appoint an Official Correspondent?

All companies selling medical devices in the US need to appoint an Official Correspondent (OC) at time of Establishment Registration. Foreign companies must appoint a US Agent, in addition to an OC. While the roles and responsibilities of a US Agent and an OC are similar, there are some key differences.

What are the responsibilities of an FDA official correspondent?

The FDA defines the Official Correspondent as the person designated by the owner/operator of an establishment who is responsible for the annual registration of the establishment and the device listing. The OC also receives correspondence from the FDA involving the owner/operator and any of the firm’s establishments. The Official Correspondent is responsible for:

• annual registration and listing of the assigned establishment, which includes:
  • creation of new registrations and listings,
  • cancellation of obsolete registrations and listings,
  • changes or updates to registration and listing information;
• adding their establishment(s) to listings previously entered for the owner/operator;
• maintaining and submitting a current list of officers and directors to the FDA upon request;
• receiving pertinent correspondence from the FDA directed to and involving the owner/operator and any of the firm's establishments.

Emergo has years of experience communicating with the FDA on our clients’ behalf. If engaged as your US Agent, we can also act as your Official Correspondent to the FDA.

The key differences between a US Agent and an official correspondent

The Official Correspondent focuses on communication with the FDA about your establishment registration and your devices listed with the FDA. Also, the OC does not need to be located in the US. However, every foreign company registered with the FDA must appoint a US Agent who has a physical residence or place of business in the US to assist with specific FDA-related responsibilities. The US Agent is responsible for FDA questions about imported devices and helps with FDA inspection scheduling, as well as communication related to the inspection.

Emergo can act as your official correspondent and US agent

Emergo provides US Agent services to more than 300 medical device companies, so we know how to handle correspondence with the FDA. When you appoint us as your Official Correspondent and US Agent, the FDA will come directly to Emergo for all inquiries and facility inspection notifications. We’ll manage your FDA communications thoroughly and smoothly.

Common FDA official correspondent questions

Must our official correspondent be the same entity as our US Agent?
No, your US Agent and OC can be different entities or individuals. However, as these roles share some similar responsibilities, it’s efficient to hire the same entity for both.

Our company is based in the US – do we still need an official correspondent?
Yes, all medical device companies registered with the FDA must appoint an OC. However, companies based in the US do not need a US Agent.