CFR 21-814 - Premarket Approval of Medical Devices

These regulations implement the FDA's criteria for and authority over class III devices requiring manufacturers requirements to submit PMA on appropriate devices.

Premarket approval (PMA) is a process by which Class II Medical Devices are approved to enter into interstate commerce. Typically, a PMA requires detailed labelling identifying the intended use of the device, clinical and nonclincial studies documenting safety and effectiveness, and a detailed summary of the medical device's design, development, verification, validation, manufacturing and distribution.