It is essential that a medical device manufacturer understand how their device will be classified prior to dedicating significant resources to the development of the device. The amount of resources (time and money) required to develop each level of device classification can vary greatly depending on the class, type of device and intended use. Frequently manufacturers will often make strategic business decisions as to whether or not the device should be developed based solely on the device classification. A majority of medical device manufacturers only develop class two devices and will not pursue class three device concepts due to the intensive resources required to develop and submit these devices for FDA Premarket Approval (PMA).
The remainder of this chapter is FDA’s explanation of medical device classifications and associated submission types. Direct references from the FDA website are noted.