医疗器械报告：制造商报告、进口商报告、用户机构报告和经销商报告——美国食品药品监督管理局。直接最终规则。

Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, and distributor reporting--FDA. Direct final rule.

出版信息

Fed Regist. 1998 May 12;63(91):26069-77.

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). FDA is publishing these amendments in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives a significant adverse comment and withdraws this direct final rule.

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。此次修订旨在实施经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。FDA正按照其直接最终规则程序发布这些修订案。在本期《联邦公报》的其他地方，FDA正在按照其通常的通知和评论程序发布一项配套拟议规则，以便在该机构收到重大负面评论并撤回此直接最终规则的情况下，提供一个程序框架来最终确定该规则。

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