What are the three classes of medical devices as categorized by the FDA?

The classification of medical devices by the FDA into Class I, Class II, and Class III is based on the level of control necessary to assure the safety and effectiveness of the device.

Class I devices are those that pose the lowest risk and are subjected to the least regulatory control. They generally require simple controls to ensure their safety, such as good manufacturing practices. Examples include tongue depressors and band-aids.

Class II devices have a moderate risk, and they require more regulatory controls than Class I devices to provide reasonable assurance of their safety and effectiveness. This often includes special labeling requirements, mandatory performance standards, and post-market surveillance. Examples include electric wheelchairs and infusion pumps.

Class III devices are the most complex and pose the highest risk. They usually require premarket approval, which involves demonstrating the safety and effectiveness of the device through clinical trials. This category is for devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or that present a potential unreasonable risk of illness or injury. An example of a Class III device is a pacemaker.

The identification of the three classes is crucial for regulatory compliance and guides manufacturers on the necessary steps to take in order to bring a device to market.