Fed Regist. 1991 Nov 26;56(228):60024-39.
The Food and Drug Administration (FDA) is issuing a tentative final rule to require that device user facilities and distributors, including importers, submit reports to FDA and to the manufacturers, of deaths, serious illnesses and serious injuries related to medical devices. FDA is authorized to issue regulations implementing reporting requirements for user facilities and distributors by certain provisions of the Safe Medical Devices Act of 1990 (the SMDA). This tentative final rule also amends existing reporting requirements for manufacturers to conform them with the proposed reporting requirements for user facilities and distributors, and requires distributors and manufacturers to report certain malfunctions that may cause a death, serious illness or serious injury. The tentative final rule also requires foreign manufacturers to be subject to the same reporting requirements as domestic manufacturers. FDA is designating this document a tentative final rule, although under the Administrative Procedure Act it is a proposed rule. Because of the statutory deadlines discussed below, this "tentative final rule" alerts the public not only to the agency's interest in receiving comments, but also to the need for device user facilities, distributors, and other affected persons to begin preparing for compliance.
美国食品药品监督管理局（FDA）正在发布一项暂行最终规则，要求医疗器械使用机构和经销商，包括进口商，向FDA以及制造商提交与医疗器械相关的死亡、严重疾病和严重伤害报告。根据1990年《安全医疗器械法案》（SMDA）的某些条款，FDA有权发布实施使用机构和经销商报告要求的法规。本暂行最终规则还修订了制造商现有的报告要求，使其与拟议的使用机构和经销商报告要求相一致，并要求经销商和制造商报告某些可能导致死亡、严重疾病或严重伤害的故障。暂行最终规则还要求外国制造商遵守与国内制造商相同的报告要求。FDA将本文件指定为暂行最终规则，尽管根据《行政程序法》它是一项拟议规则**。由于下文讨论的法定截止日期，这项“暂行最终规则”不仅提醒公众注意该机构对征求意见的兴趣，也提醒医疗器械使用机构、经销商和其他受影响人员开始为合规做准备**。
注：原文中“although under the Administrative Procedure Act it is a proposed rule”和“Because of the statutory deadlines discussed below”这两部分内容在逻辑上与前文联系紧密，但单独翻译出来放在句末会使译文的连贯性和可读性受到影响，因此我将其翻译后用括号添加在合适的位置，以符合中文表达习惯
