| 美国医疗器械管理与临床研究现状 |
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| 引用本文： | 王洋,顾汉卿. 美国医疗器械管理与临床研究现状[J]. 透析与人工器官, 2007, 18(3): 31-42 |
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| 作者姓名： | 王洋 顾汉卿 |
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| 作者单位： | 300070天津,天津医科大学 |
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| 摘 要： | 在美国,医疗器械的临床研究是建立在医疗器械分类管理的基础之上,是一部分医疗器械在上市前必须经过的步骤之一,也是保证医疗器械安全性和有效性的方法之一。临床试验的进行必须遵守器械临床试验豁免(investigational device exemption,IDE)的规定,以良好控制的临床试验为基础,以完整准确的数据分析为结论。
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| 关 键 词： | 医疗器械 分类管理 上市前通知(510(k)) 上市前批准(PMA) 临床研究 器械临床实验豁免(IDE) |
| 文章编号： | 1005-0809（2007）03-0031-12 |
| 修稿时间： | 2007-08-02 |
American Medical Device Management and Clinical Studies |
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| WANG Yang,GU Han-qing. American Medical Device Management and Clinical Studies[J]. Chinese Journal of Dialysis and Artificial Organs, 2007, 18(3): 31-42 |
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| Authors: | WANG Yang GU Han-qing |
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| Affiliation: | Tianjin Medical University, Tianjin 300070, China |
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| Abstract: | In America,clinical studies on medical device are based on the classification strategy of medical device,which is one of the necessary steps before device can bring into the market,and also a way of assuring the safety and effectiveness of medical device.The conducting of clinical studies must follow the IDE regulation,with good clinical practice as its basis,complete and accurate data as its conclusion. |
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| Keywords: | medical device classification management premarket notification(510(k)) premarket approval clinical studies investigational device exemption |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ |
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