Last week, Yale University’s School of Medicine’s Journal, The Journal of the American Medical Association, published a new study examining the testing process for high-risk medical devices.  Specifically, the study compared the number of premarket and postmarket clinical studies conducted by the Food and Drug Administration (FDA) as part of the agency’s premarket approval (PMA) pathway.

Researchers studied 28 high-risk medical devices approved in 2010 and 2011. For the 28 devices, the FDA conducted 286 clinical studies; however, a disproportionate amount of testing, more than 70 percent, was conducted after the device was released on the market. The study found that despite minimal premarket testing, five devices received no postmarket testing, while nearly half of the remaining devices saw three or less postmarket studies. Notably, 10 of the 28 devices were eventually recalled.

Accordingly, the study concluded that the “findings of limited premarket evidence generation and few FDA-required postmarket studies highlight the need for continued study, either through manufacturer-initiated or investigator-initiated studies, to advance postmarket understanding of device safety and effectiveness.”  The authors of the study also put the findings into perspective citing proposed legislation, such as the 21st Century Cures Act, to further reduce the testing requirements for new drugs and medical devices.


JAMA Study: