Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices.

The article discusses a study which investigated premarket approval (PMA) of cardiovascular devices by the U.S. Food and Drug Administration (FDA). The study also attempted to characterize the type and strength of evidence of which the FDA review process is based. The authors systematically reviewed summaries of safety and effectiveness data for 78 PMA for high-risk cardiovascular devices approved between January 2000 and December 2007. They concluded that premarket approval was often based on studies that lack adequate strength and may be prone to bias.