FLYER | FDA Authorization procedures for Medical Devices – (PMA)

Premarket Approval

A Premarket Approval (PMA) is the most stringent type of FDA marketing application required for high-risk Class III medical devices. It involves a thorough review of scientific and clinical data to ensure a device’s safety and effectiveness before it can be sold in the United States.

Discover when PMA is required and the key steps of the process with this flyer.