United States government regulation of medical device software: a review.
United States government regulation of medical device software: a review.
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美国政府对医疗设备软件的监管：审查。
DOI：
10.3109/03091909009015422
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发表时间：
1990
影响因子：
--
通讯作者：
R. Murfitt
中科院分区：
文献类型：
--
作者：
R. Murfitt
介绍了美国医疗器械软件监管的简要历史，并讨论了美国食品和药物管理局(FDA)提出的修改软件监管要求的理由，而不是以前用于硬件设备的要求。讨论了两类医疗器械软件的当前监管状况，即医疗器械内使用的软件和用于生产或测试医疗器械的软件。总结和讨论了FDA发布的文件，这些文件确定了当前软件监管的环境。这两类医疗器械软件涉及FDA监管的两个领域，良好的制造规范和销售医疗器械的许可。讨论了未来医疗器械软件监管的预期方向及其与欧洲经济共同体(EEC)和国际市场的关系。
A brief history of the regulation of medical device software within the United States is presented, along with a discussion of the reasoning that the US Food and Drug Administration (FDA) presents for modifying the requirements for software regulation from those previously used for hardware devices. The current regulatory status is discussed for the two categories of medical device software, software used within medical devices and software used to produce or test medical devices. The published FDA documents which determine the current environment for the regulation of software are summarized and discussed. The two types of medical device software are related to the two areas of FDA regulation, good manufacturing practices and permission to sell medical devices. The expected direction of future medical device software regulation, and its relationship to the European Economic Community (EEC) and international markets is discussed.