Researchers called on the FDA to beef up post-market requirements for its breakthrough devices program.
The call to tighten requirements was based on the results of a study by researchers from the University of California San Francisco School of Medicine and the Yale University School of Medicine, published in JAMA Internal Medicine, that evaluated clinical trials to assess the safety and efficacy of cardiovascular devices approved through the agency’s priority review program.
The study notes that the breakthrough therapy designation under the 21st Century Act allows the FDA to accept “a greater degree of uncertainty of the benefit-risk profile for these devices if the uncertainty is sufficiently balanced by other factors … and adequate post-market controls to support premarket approval.”
Researchers compared high-risk cardiovascular devices approved from Jan. 1, 2017 to Dec. 31, 2017 through the original pre-market process under the priority review program.
FDA advisory panels reviewed 10 of the devices, and two were reviewed a second time. Post market clinical studies were required for 13 of the 14 devices, and for these devices there have been two Class I and 13 Class II recalls for six of the 14 devices. Nearly half of the FDA expert advisory panels deemed the devices safe but not effective, the study authors said.
Read the study report here: https://bit.ly/2Njpl8Z.