For every medical device, whether it involves risk or not, it needs to be regulated by FDA. And the center that regulates the medical devices is CDRH which is the Center for Devices and Radiological Health. They review and approves medical devices. Each device is classified into class I, class II, and class III. Class I are the most general devices and they are exempt from pre-market notification. Class II requires some risk and controls. It requires 510(k) documents FDA regulations. lastly, Class III requires serious control and also premarket approval application in order to market the device.