Sep 12, 2012

The US Food and Drug Administration has published a list of frequently asked questions regarding new medical device registration and listing requirements that go into effect October 1, 2012.

Key changes covered in the FDA FAQ include:

  • All contract manufacturers of finished devices must register and list with the FDA even if they do not commercially distribute devices themselves
  • Foreign firms exporting devices to the US must identify all US importers of their products
  • All establishments that must register with the FDA must now also pay annual registration user fees
  • Firms located in foreign trade zones must now register and list with the FDA, and identify themselves as located in foreign trade zones

Registrants must also inform the FDA of all current proprietary and white-label names of their devices, as well as use lists in the FDA Unified Registration and Listing System (FURLS) in order to identify combination products with both medical device and biological or pharmaceutical components.

All medical device manufacturers currently marketing their products or considering commercialization in the US should take into account these upcoming changes to determine how their existing or future FDA medical device registrations will be impacted.


  • Stewart Eisenhart