What is the 510(k)?

The 510(k), or Premarket Notification, is the FDA most frequently required process to medical device manufacturers to market their devices in the US. The 510(k) is different from the PMA process, or Premarket Approval, and it’s possible to establish whether the US Regulation requires a 510(K) or a PMA by identifying the most suitable Product Code for the medical device to be marketed in USA.

The 510(k) procedure consists of demonstrating the substantial equivalence between the medical device subject to FDA approval and at least one medical device with same intended use and similar technical characteristics (predicate device) already on the US market. Demonstrating the substantial equivalence means proving to the FDA that the device to be registered is as much safe and efficient as the predicate device.