In my opinion, I don’t think it is necessary to have a separate classification for the device as the function of the device is already known in the market or FDA database. If the FDA finds the devices with more risks than normal it would lead them to classify differently. Therefore, I think it is based on the risk of the device that it can be classified among three class. Furthermore, the departments such as regulatory and quality controls will significantly review the device to prevent a hazardous product from releasing in the market.