PMA is a process brought in practice by FDA (Food and Drug Administration) to review a medical device for safety and effectiveness evaluation. For class III medical devices, there is high level of risk associated. FDA forces PMA under section 515 of the FD&C Act to assure the safety before bringing any device to market. PMA application is an instrument to provide a valid evidence to prove that device is safe and effective for the claimed use by collecting data from human clinical trials. If a manufacturer wishes to market a new kind of device, which is not available in market or having a different material or different design than previously available devices, to ensure the primary safeguard of user, manufacturer must submit a premarket approval application to the FDA for review. A manufacturer must receive approval in response to PMA application before they start to market a device. FDA authorities provide a time of 180 days to make an approval decision, but generally, it takes more time before approving or denying the premarket approval application.
