The FDA’s CDRH (Center for Devices and Radiological Health) follows a set of protocols to classify medical devices as class 1, class 2 or class 3 device depending on the risks involved with the device. Class 1 device are devices that do not have any associated risks with it and hence and are exempt from premarket notification 510(k) while class 2 devices do need a premarket notification 510(k) due to the moderate risks associated and finally the class 3 devices need a premarket approval (PMA) because of the high risks related to these devices. The class 3 devices need to submit claims of clinical trials in support of the device.