How Rigorous Is the Premarket Approval Process for Cardiovascular Devices?

The FDA must approve medical devices used in the U.S., but how strong is the evidence considered in such assessments? Dhruva and colleagues used the FDA database to systematically review the studies included in premarket approval of all class III cardiovascular devices from 2000 through 2007. Class III devices are defined as “usually 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.”

The FDA approvals cited 123 studies; only 33 studies were randomized, and 14% were blinded. Of 78 approvals, only about one third were based on at least one randomized trial, and only 13% were based on at least one blinded study. …