医疗器械；30天通知和135天的上市前批准补充审查——美国食品药品监督管理局。最终规则。
Medical devices; 30-day notices and 135-day PMA supplement review--FDA. Final rule.
出版信息
Fed Regist. 1998 Oct 8;63(195):54042-4.
PMID:10185825
Abstract
The Food and Drug Administration (FDA) is amending its regulations governing the submission and review of premarket approval (PMA) supplements to provide for the submission of a 30-day notice for modifications to manufacturing procedures or methods of manufacture. 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）正在修订其关于上市前批准（PMA）补充申请的提交和审查的法规，以便规定就制造程序或制造方法的变更提交30天通知。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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