PMA Advisory Panels: Do Their Votes MatterMay 1, 2019 Download PDF
Under the Federal Food, Drug, and Cosmetic Act, devices fall into three classes. The premarket approval
(PMA) is the route to market for Class III devices, the highest risk medical devices.
A Class III device is a device that cannot be classified as a Class I or II device because “insufficient information exists to determine that the application of” general and/or special controls would “provide a reasonable assurance of safety or effectiveness” and “is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health” or “presents a potential unreasonable risk of illness or injury.”
- Jeffrey N. Gibbs