Fed Regist. 1998 Nov 18;63(222):63983.
The Food and Drug Administration (FDA) published in the Federal Register of August 7, 1998 (63 FR 42229), a direct final rule. The direct final rule notified the public of FDA's intention to amend the regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. This document delays the effective date of the direct final rule.
美国食品药品监督管理局(FDA)于1998年8月7日在《联邦公报》(63 FR 42229)上发布了一项直接最终规则。该直接最终规则向公众通报了FDA打算修订有关医疗器械更正和召回报告的法规,以取消经销商提交此类报告的要求。本文件推迟了该直接最终规则的生效日期。