医疗器械报告：制造商报告、进口商报告、使用机构报告、经销商报告。美国卫生与公众服务部食品药品管理局。最终规则。

Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Food and Drug Administration, HHS. Final rule.

出版信息

Fed Regist. 2000 Jan 26;65(17):4112-21.

Abstract

The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors and health care (user) facilities of adverse events related to medical devices. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

摘要

美国食品药品监督管理局（FDA）正在修订其关于制造商、进口商、经销商及医疗保健（用户）机构报告医疗器械相关不良事件的规定。此次修订是为了实施经1997年《食品药品管理局现代化法案》（FDAMA）修订的《联邦食品、药品和化妆品法案》（该法案）的相关修订内容。

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