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1976年以前,美国各州都相继颁布了一些医疗设备市场准入制度对医疗设备进行监管。自1976年美国《医疗设备修正案》颁布以后,国会授权美国食品与药品管理局(以下简称FDA)对医疗设备进行前市场准入许可监管。而该法案中的优先适用条款给出的适用范围却有待进一步商榷,对此进行研究以期对我国的医疗设备方面的统一标准的制定、完善和适用提供有益帮助,使现行法律法规更加符合我国国情。
Before 1976, all states in the United States have promulgated a number of medical equipment market access system to regulate medical equipment. After the U.S. Medical Device Amendment was enacted in 1976, Congress authorized the U.S. Food and Drug Administration (FDA) to supervise pre-market permission for medical devices. However, the scope of application of the preferential provisions in the act still needs to be further discussed. This study is carried out in order to provide useful help for the formulation, perfection and application of the uniform standard in the medical equipment in our country so as to make the current laws and regulations more in line with China’s national conditions .