Fed Regist. 2004 Aug 23;69(162):51765-6.
The Food and Drug Administration is amending the identification and classification regulations of gold-based alloys and precious metal alloys for clinical use and base alloys devices in order to designate a special control for these devices. FDA is also exempting these devices from premarket notification requirements. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance documents that would serve as special controls for these devices.
美国食品药品监督管理局（FDA）正在修订临床用金基合金、贵金属合金及基础合金器械的识别与分类规定，以便对这些器械指定特殊控制措施。FDA还将这些器械免于上市前通知要求。该机构主动采取此项行动。此行动依据经1990年《安全医疗器械法案》（SMDA）及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）采取。在本期《联邦公报》的其他地方，FDA宣布了将作为这些器械特殊控制措施的指导文件草案的可用性。
