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首页> 外文期刊>The Journal of the American Academy of Orthopaedic Surgeons >Medical Device Regulation: A Comparison of the United States and the European Union
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Medical Device Regulation: A Comparison of the United States and the European Union

机译：医疗器械法规：美国和欧盟的比较

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摘要

Medical device regulation is a controversial topic in both the United States and the European Union. Many physicians and innovators in the United States cite a restrictive US FDA regulatory process as the reason for earlier and more rapid clinical advances in Europe. The FDA approval process mandates that a device be proved efficacious compared with a control or be substantially equivalent to a predicate device, whereas the European Union approval process mandates that the device perform its intended function. Stringent, peer-reviewed safety data have not been reported. However, after recent high-profile device failures, political pressure in both the United States and the European Union has favored more restrictive approval processes. Substantial reforms of the European Union process within the next 5 to 10 years will result in a more stringent approach to device regulation, similar to that of the FDA. Changes in the FDA regulatory process have been suggested but are not imminent.
机译：在美国和欧盟，医疗器械法规都是一个有争议的话题。美国的许多医师和创新者都将限制性的FDA监管程序作为欧洲早期和快速临床发展的原因。 FDA批准程序要求与对照相比，该设备应被证明是有效的，或者实质上等同于谓词设备，而欧盟批准程序则要求该设备执行其预期功能。尚未报告过严格的，经过同行评审的安全数据。但是，在最近备受瞩目的设备故障之后，美国和欧盟的政治压力都倾向于采用限制性更强的审批程序。在接下来的5至10年内，欧盟流程将进行实质性改革，这将导致与FDA相似的更严格的设备监管方法。已经提出了FDA监管程序的变化，但并非即将发生。

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