Makow L S
Stanford Law Rev. 1994 Feb;46(3):709-46.
Medical devices marketed in the United States must satisfy FDA standards of safety and effectiveness. Many observers have criticized the FDA medical device review process as both time consuming and unpredictable. In this note, Lawrence Makow examines the Agency's treatment of two novel medical technologies, magnetic resonance spectroscopy and biliary extracorporeal shockwave lithotripsy. He concludes that the outcomes of these cases exemplify the mismatch between clinical utility and FDA approval status that has prompted concerns about lack of predictability. Mr. Makow asserts that this mismatch results from the FDA's implementation of the medical device statute rather than from the statute itself. He proposes an asymmetric standard for evaluating the safety and efficacy of new medical devices. While the safety showing would always require a high burden of proof, the efficacy standard would vary depending on the relationship between the device's safety and efficacy. Under this asymmetric standard, the FDA could better manage its workload and achieve more predictable results without sacrificing the public interest in avoiding injury from unproven medical devices.
在美国销售的医疗设备必须符合美国食品药品监督管理局（FDA）的安全和有效性标准。许多观察家批评FDA的医疗设备审查过程既耗时又不可预测。在本报告中，劳伦斯·马科研究了该机构对两种新型医疗技术——磁共振波谱和体外冲击波碎石术的处理情况。他得出结论，这些案例的结果体现了临床效用与FDA批准状态之间的不匹配，这引发了人们对缺乏可预测性的担忧。马科先生断言，这种不匹配是由于FDA实施医疗器械法规造成的，而非法规本身。他提出了一种用于评估新型医疗设备安全性和有效性的不对称标准。虽然证明安全性始终需要很高的举证责任，但有效性标准将根据设备安全性和有效性之间的关系而有所不同。根据这一不对称标准，FDA可以更好地管理其工作量，并在不损害公众避免因未经证实的医疗设备而受伤的利益的情况下，取得更可预测的结果。
