The FDA regulates a wide range of medical devices, including, pacemakers, cardiovascular stents, respiratory ventilators, breast implants, diagnostic tests (pregnancy tests, blood glucose tests, etc.) and relatively simple devices such as tongue depressors, patient scales, and elastic bandages.
Medical devices are classified based on the risks associated with the use of the device. Devices are classified as Class I, Class II, or Class III, Class I being the lowest risk and Class III the highest risk.
- Class I – Devices that have minimal potential for harm to the user. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the pre-market review process.
- Class II – A majority of medical devices are considered. Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits.
- Class III – These devices usually sustain or support life, are implanted, or present potential high risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.
Some devices may be considered “exempt”. If a device is considered “exempt”, the manufacturer would not be required to submit a premarket notification submission [510 (k) submission] and obtain FDA clearance before marketing the device in the U.S. Examples of exempt devices include Class I devices and some Class II devices such as manual stethoscopes, mercury thermometers, AC-powered adjustable hospital beds, powered heating pads, and bedpans. However, the manufacturer is required to register their establishment and list their devices with the FDA.