Want to know whether the equivalent device of your device is a registered device with USFDA or not? Is it listed with USFDA?
Not sure where to look for this establishment registration? Well, FDA has already provided us with an amazing database, where we can look for all the registrations and the listing along with the locations of the manufacturers and the devices manufactured by these organizations.
You can use below link to visit the portal –
Link for the Database –
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
Link for the Establishment Registration and Medical Device Listing Files for Download –
It is called as Establishment Registration and Listing Database.
Generally, this database is updated with the new data every Monday (weekly update of the database).
Technical Experts available at Maven can help you out with the proper search of your equivalent device through this database.
December 3rd, 2024
December 3rd, 2024