what is a pma

A PMA stands for Premarket Approval, which is a process of scientific and regulatory review by the FDA to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. The PMA is the most stringent type of device marketing application required by the FDA, and the applicant must receive FDA approval of its PMA application prior to marketing the device. The PMA application is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the Class III device, and it includes reports of all known information about the device’s safety and effectiveness, description of the device, including its components, ingredients, properties, and operating principles, description of the device’s manufacturing and processing, results of non-clinical trials (bench/animal testing), results of any clinical studies, and more. The PMA review is a multi-step process that typically includes an initial review to confirm that an application is complete, an in-depth scientific and regulatory review, a manufacturing quality and bioresearch audit, review and recommendation by an advisory committee, and final deliberations and notification of FDA’s decision.