U.S. FDA Registration and Medical Device Listings
U.S. FDA CITATION: 21 C.F.R. Part 801 et seq.
The U.S. FDA is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. For devices that are exempt from Premarket Notification, Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of medical devices must register their establishments with the U.S. FDA. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Beginning October 1, 2007, most establishments are required to pay an establishment registration fee. The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective October 1, 2012.
If you are not registered with U.S. FDA
Registrar Corp’s team of Medical Device Regulatory Specialists provides guidance on required elements, formats, and particularities of submissions, including:
- Help determining whether registration exclusions apply and, if not, we will prepare and submit your registrations with U.S. FDA and make changes, updates and cancellations as needed at no extra cost.
- Assistance determining if U.S. FDA Medical Device User Fees are required for your registration and, if so, help prepare and submit your payment per U.S. FDA’s requirements.
- Issuance of Certificates of Registration to assure customers that you have a valid U.S. FDA Registration as well as prevent the accidental loss of your critical information.
If you are already registered with the U.S. FDA
Select one of the following options:
- Option 1: List Additional Medical Devices, Manufacturers, Importers or Proprietary Names With U.S. FDA
The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) requires companies to list new manufacturers, importers or proprietary names with their Medical Device Establishment Registration. Registrar Corp’s team of Medical Device Regulatory Specialists help companies update their FDA registrations:
- Option 2: Change U.S. FDA Official Correspondent and U.S. Agent
It is prudent to separate commercial relationships from the responsibilities of your Official Correspondent for U.S. FDA communications because of potential conflicts of interests. Correct this by designating Registrar Corp as your Official Correspondent for U.S. FDA Communications and receive your Certificate of Registration issued by Registrar Corp.
- Option 3: Order a Certificate of Registration
Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their registration. A Certificate of Registration issued by Registrar Corp serves to verify your compliance with the registration requirement of the U.S. Food, Drug and Cosmetic Act.