FDA Device Registration and Listing
Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States are mandated to register annually with the FDA. Most establishments that are required to register have to list the devices, functions and the activities performed on those devices.
Registration and listing information is submitted by using FDA's Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM). An annual establishment registration user fee must be paid to the FDA for device establishment.
MDSS performs the establishment registration and device listing on the behalf of our clients.