MEDICAL DEVICE REVIEW AT THE FOOD-AND-DRUG-ADMINISTRATION - LESSONS FROM MAGNETIC-RESONANCE SPECTROSCOPY AND BILIARY LITHOTRIPSY

Medical devices marketed in the United States must satisfy FDA standar ds of safety and effectiveness. Many observers have criticized the FDA medical device review process as both time consuming and unpredictabl e. In this note, Lawrence Makow examines the Agency's treatment of two novel medical technologies, magnetic resonance spectroscopy and bilia ry extracorporeal shockwave lithotripsy. He concludes that the outcome s of these cases exemplify the mismatch between clinical utility and F DA approval status that has prompted concerns about lack of predictabi lity. Mr. Makow asserts that this mismatch results from the FDA's impl ementation of the medical device statute rather than from the statute itself. He proposes an asymmetric standard for evaluating the safety a nd efficacy of new medical devices. While the safety showing would alw ays require a high burden of proof, the efficacy standard would vary d epending on the relationship between the device's safety and efficacy. Under this asymmetric standard, the FDA could better manage its workl oad and achieve more predictable results without sacrificing the publi c interest in avoiding injury from unproven medical devices.