The FDA has described and classified over 1,700 distinct types of medical devices and organized them into 16 specialty panels (e.g., Cardiovascular Devices). For each of the medical devices classified by the FDA, the 21 CFR gives a general description, the intended use, the class to which the device belongs, and information about marketing requirements.

The FDA recognizes three classes of medical devices based on the risk of the medical device and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. The more risk involved in the normal use of a medical device, the higher the classification. 21 CFR also lists why something falls into one class or another.

The FDA periodically reviews classifications either spontaneously or at the request of a manufacturer and may adjust the classification of a medical device based on new information.

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.