Findings Suggest Cardiovascular Devices Often Approved By FDA Without High-Quality Studies
JAMA - Journal of the American Medical AssociationPre-market approval by the FDA of cardiovascular devices is often based on studies that lack adequate strength or may have been prone to bias, according to a study in the December 23/30 issue of JAMA. The researchers found that of nearly 80 high-risk devices, the majority received approval based on data from a single study.