| 美国医疗器械立法嬗变及其动因 |
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| 引用本文： | 董春华. 美国医疗器械立法嬗变及其动因[J]. 时代法学, 2011, 0(5): 101-108 |
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| 作者姓名： | 董春华 |
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| 作者单位： | 中国政法大学法学院; |
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| 基金项目： | 作者主持的2010年度国家社科基金青年项目“缺陷医疗器械侵权责任实证研究”(项目编号:10CFX050)的阶段性研究成果之一 |
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| 摘 要： | 1938年《联邦食品药品及化妆品法》和1976年《医疗器械法》是两个具有里程碑意义的法律。某种程度上,每一部法律的制定都是灾难性事件的杰作。而在立法进程中,立法者都在促进医疗器械安全与鼓励新医疗器械的发展上进行着一种平衡,美国联邦食品药品管理局在执行这些立法过程中更追求这种平衡。中国医疗器械安全立法及侵权法都忽视了这一点,一味追求对医疗器械生产商和医疗机构课以责任。
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| 关 键 词： | 医疗器械 立法 利益平衡 |
The Process of Legislation of American Medical Device and Its Motivation |
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| DONG Chun-hua. The Process of Legislation of American Medical Device and Its Motivation[J]. Presentday Law Science, 2011, 0(5): 101-108 |
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| Authors: | DONG Chun-hua |
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| Affiliation: | DONG Chun-hua(Law School of China University of Political Science and Law,Beijing 100088,China) |
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| Abstract: | Federal Food,Drug and Cosmetic Act of 1938 and Medical Device Amendment of 1976 are the milestones in the legislative history.To some extent,each Act is the outcome of the catastrophe.During the process of the legislation,legislators have balance of promotion of the safety of medical device and the creation of the new medical device.Federal Food and Drug Bureau practiced the balance during the implementation of the Acts.The legislation of medical device in China ignored this and searched much to imputate th... |
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| Keywords: | medical device legislation balance of interests |
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