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.
