ビジネス · 1998/8/111 分で読めます
Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA) published, in the Federal Register of April 27, 1998 (63 FR 20530), a direct final rule to implement the amendments to the premarket approval provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed on July 13, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.