As defined in the 510(k) section of the Food, Drug and Cosmetics Act, device manufacturers should notify the FDA at least 90 days in advance of their intention of marketing a medical device. The process of notification is known as Premarket Notification or PMN. Based on this notification, FDA determines the substantial equivalence of the device and places it into one of the three classification categories. This process helps FDA to identify all new devices which have not been identified till date.
