首页> 美国政府科技报告 >Federal Register Volume 60 No. 237, Monday, December 11, 1995 Rules andRegulations. Part 2. 21 CFR Part 803, et al.; Volume 61 No. 71, Thursday, April 11, 1996 Rules and Regulations; Volume 61 No. 106, Friday, May 31, 1996 Notices

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Federal Register Volume 60 No. 237, Monday, December 11, 1995 Rules andRegulations. Part 2. 21 CFR Part 803, et al.; Volume 61 No. 71, Thursday, April 11, 1996 Rules and Regulations; Volume 61 No. 106, Friday, May 31, 1996 Notices

机译：联邦登记册第60卷第237号，1995年12月11日，星期一规则和规定。第2部分.21 CFR part 803，et al。; 1996年4月11日，星期四，第61卷，第71号，规则和条例; 1996年5月31日星期五第61卷第106号通知

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The Food and Drug Administration (FDA) is issuing regulations requiring medicaldevice user facilities and manufacturers to report adverse events, related to medical devices, under a uniform reporting system. This regulation is mandated by the Safe Medical Devices Act of 1990 (SMDA) and prescribes the conditions under which reports must be submitted, the content and timing of the requisite reports, and how FDA will utilize the information in carrying out its public health protection responsibilities. This rule is intended to augment the agency's postmarket surveillance activities and public health protection responsibilities relating to medical devices.

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年度 1996
页码 p.1-37
总页数 37
原文格式 PDF
正文语种 eng
中图分类工业技术;
关键词
Compliance; Medical devices; Regulations; Reporting;

机译：合规;医疗器械;法规;报告;

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1. Report from the Commission on the implementation of decision No. 2496/96/ECSC of 18 December 1996 establishing Community rules for aid to the steel industry (Steel Aid Code) in 1997. COM (98) 140 final, 11 March 1998 [O] . 1998

机译：委员会关于1996年12月18日第2496/96 / ECsC号决定执行情况的报告，1997年确立了钢铁工业援助共同体规则（钢铁援助法）.COm（98）140最后，1998年3月11日
2. Federal Register Volume 61 No. 195, Monday, October 7, 1996 Rules andRegulations. Part 7. Department of Health and Human Services, Food and Drug Administration. 21 CFR Parts 808, 812, and 820 Medical Devices; Current Good Manufacturing Practice (CGMP); Fi [R] . 1997

机译：联邦登记册第61卷第195号，1996年10月7日，星期一规则和规定。第7部分。健康与人类服务部，食品药品管理局。 21 CFR parts 808,812和820医疗器械;现行良好生产规范（CGmp）;网络连接

Federal Register Volume 60 No. 237, Monday, December 11, 1995 Rules andRegulations. Part 2. 21 CFR Part 803, et al.; Volume 61 No. 71, Thursday, April 11, 1996 Rules and Regulations; Volume 61 No. 106, Friday, May 31, 1996 Notices

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