The FDA’s Center for Devices and Radiological Health (CDRH) has added a new section to the existing How to Register and List webpage. The new section titled, “Downloading your Listing Information from FURLS” provides instructions for the owner/operator or official correspondent of registered establishments to download listing information from the FDA’s Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM).
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register with the FDA. This process is known as establishment registration (Title 21 CFR Part 807). A device facility must register its establishment and list its devices with the FDA before marketing the devices.
You can learn more about the establishment registration by accessing the Device Registration and Listing webpage. There are also registration and listing tutorials through the CDRH Learn website under the “Start Here/The Basics!” section.