How Safe and Effective Is the FDA's Priority Review Program?

Many cardiovascular devices are deemed by the FDA to be Class III, defined as “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” (U.S. Food and Drug Administration. Premarket Approval [PMA]. Mar 27, 2018). The FDA's premarket approval process addresses the safety and effectiveness of these devices. To evaluate the Priority Review Program, which expedites these evaluations, investigators studied all pivotal studies that supported all Class III cardiovascular devices approved from January 2007 through December 2017.

Cardiovascular devices accounted for 14 of all 29 devices approved via priority review during the…