FDA MEDICAL DEVICE ESTABLISHMENT REGISTRATION 

Establishments that produce and distribute medical devices that are marketed in the United States must register with the FDA through a process know as "Establishment Registration."

The establishment registration process allows the FDA to be notified of the location of medical device manufacturing facilities and importers. It is important to note that registration of an establishment is not equivalent to FDA clearance or approval to market a medical device. Unless the product is classified as exempt, 510(k) premarket clearance or PMA approval from the FDA is required before the medical device can be commercially distributed in the United States.