Useful Device Registration Links
Device Registration and Listing - how to register a business that is involved in the production and distribution of medical devices intended for use in the United States (U.S.). This site provides info regarding who needs to register and how to pay the fee, including the annual fees.
Note: All device establishments must complete their annual registration for each Fiscal Year between October 1 and December 31
Access Electronic Registration – This link will take you to access the electronic registration and listing system.
(here is a tutorial guide for new users): https://www.fda.gov/food/online-registration-food-facilities/fda-industry-systems-account-management-guide
FDA Unified Registration and Listings System (FURLS) Database. The FURLS database is a separate database where companies register facilities and list devices with the FDA
This link will take you to the tutorial: https://www.accessdata.fda.gov/cdrh_docs/presentations/FURLS-InitialRegistration/story.htm
Compiled by James Shore, Past Chair