Premarket approval application (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices support or sustain human life, are critically important to prevent the impairment of human health, or present a potential, unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application that FDA requires.
To market a Class III device, the premarket approval application (PMA) must establish a “reasonable assurance of safety and effectiveness,” as demonstrated by valid scientific evidence. Safety means that the device’s probable benefits outweigh its probable risks, and effectiveness is measured by looking at clinically significant results for the target population for the device. Valid scientific evidence includes clinical studies and trials, case histories, and reports of significant human experience.