FDA Establishment Registration & Device Listing using FURLS
If you would like to sell or distribute a medical device in the United States, you must register your 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 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.
The FDA also charges fees that you should review.
Emergo Group can complete the FDA online registration for you. Please contact us for more information.
