The USFDA Premarket Approval (PMA) process is one of the device registration pathways provided by the US FDA, primarily designed for FDA Class III medical devices. The FDA PMA approval process for Class III devices entails meticulous scientific and regulatory evaluations to assess the medical device's safety and efficacy, ensuring the highest standards are met prior to the market authorization.
Device manufacturers must submit a PMA application if the device:
Is novel.
Belongs to a high-risk class.
Cannot be found in the Product Classification Database.
Is not substantially equivalent (NSE) to Class I, II, or III devices.