FDA Registration Using the FURLS System

If you would like to sell or distribute a medical device in the United States, you must register your device and company with the Food and Drug Administration (FDA).

If you manufacture a Class II or Class III device, you must first obtain FDA 510(k) clearance or Premarket Application (PMA) approval from the FDA. Most Class I devices do not require clearance or approval. For all classes of devices, the final step is to complete the Establishment Registration and Device Listing online using the FDA online registration tool called FURLS. Overseas manufacturers must also appont a US Agent based in the USA.

The FDA also charges fees that you should review.

Emergo Group can prepare FDA 510(k) submissions, bring you into compliance with FDA Good Manufacturing Practice (GMP), act as your US Agent and complete the FDA online registration for you.

Please contact us for more information.