ABSTRACT
Regulation of medical devices is intended to protect consumer's health. Section 510(k) of the Food~ Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance~ of their intent to market a medical device. This is known as Premarket Notification, also called PMN or 510(k). It allows FDA to detennine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distributiol1 prior to May 28, 1976) that have not been classified can be properly identified.
