Useful Device Registration Links

Published

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

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

 

Access Electronic Registration – This link will take you to access the electronic registration and listing system.

https://www.fda.gov/medical-devices/device-registration-and-listing/access-electronic-registration

(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

Share: