How does FDA review medical devices before they can be sold?
Manufacturers wishing to sell any new products that contain new materials or differ in design from products already on the market must submit a Premarket Approval (PMA) application to FDA. A PMA must provide valid scientific evidence that includes data from human subjects showing the product does what it claims to do effectively, and it does not present any unreasonable risks to the patient. The majority of medical devices are cleared through the premarket notification process (also called 510(k)), a less rigorous process than the premarket approval process. Some devices are exempt from both processes.
