High risk devices backed by few studies before and after FDA premarket approval

Editor's Note

Many high risk therapeutic devices receive Food and Drug Administration (FDA) premarket approval with few studies to back their safety and efficacy, Yale researchers find. Studies of how the devices perform once on the market also are few.

Of 28 high risk devices that received premarket approval between 2010 and 2011, the FDA relied on about one study per device for approval, and there were 33 postmarket studies for the 28 devices. Five devices had no postmarket studies. Fifteen of the 28 devices were new stents; 10 were later recalled from the market.

Importance The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle.