| 美国医疗器械法规介绍 |
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| 引用本文： | 屈宝刚. 美国医疗器械法规介绍[J]. 中国医疗器械信息, 2005, 11(1): 24-25 |
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| 作者姓名： | 屈宝刚 |
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| 作者单位： | 国家食品药品监督管理局医疗器械技术审评中心,北京,100044 |
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| 摘 要： | 文章首先介绍了FDA的机构组成,着重阐述了医疗器械在美国上市的两个途径,以及FDA是如何通过质量体系来控制和监管医疗器械生产厂的,最后简单的介绍了美国的临床试验申请和产品上市后监督的一些法规情况.
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| 关 键 词： | 上市前审批 临床试验 质量管理体系 |
| 文章编号： | 1006-6586(2005)01-0024-02 |
| 修稿时间： | 2004-11-19 |
Medical Device Regulation in the United States--An Overview |
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| QU Bao-gang. Medical Device Regulation in the United States--An Overview[J]. China Medical Devices Information, 2005, 11(1): 24-25 |
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| Authors: | QU Bao-gang |
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| Affiliation: | Beijing 100044 |
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| Abstract: | First, the paper presents a view of the administration organization of FDA, Explains two approaches (510(k) and PMA) that the medical device is marketed on U.S.A. emphatically. Then readers can know how is FDA control and supervise medical device factory to come through quality system. In the end of the paper, the concept of IDE( Investigational Device Exemption) application and substantial regulation which is post-market surveillance has also been provided. |
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| Keywords: | pre-market approval IDE QSR |
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