• 主题
高级搜索  >
历史搜索 清空历史
首页> 美国政府科技报告 >Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992
【24h】

Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992

机译：1990年安全医疗器械法和1992年医疗器械修正案

获取原文
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

The booklet updates a previous Center for Devices and Radiological Healthpublication. Highlights of the Safe Medical Devices Act of 1990 (Public Law 101-629). The Safe Medical Devices Act of 1990 (SMDA), which became effective on November 26, 1990, gave the Food and Drug Administration (FDA) several new authorities and expanded and modified previous medical device requirements. After the Highlights booklet was published, Congress enacted the Medical Device Amendments of 1992 (the 1992 Amendments), which changed some of the provisions of SMDA. The revised booklet reflects the requirements of both statutes. The booklet addresses SMDA's new enforcement authorities for FDA, among which are the reporting of medical device problems to FDA by user groups and distributors. It also describes changes in device classification and reclassification, changes that affect the premarket notification and premarket approval processes, and changes that affect the good manufacturing practices requirements. It gives the effective dates of the new provisions and also lists Federal Register documents that apply to SMDA.

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号