Fed Regist. 2000 Jan 14;65(10):2296-323.
The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices.
美国食品药品监督管理局（FDA）正在修订其分类法规，以指定某些符合特定限制条件、可免于上市前通知要求的I类器械，并根据新的上市前通知要求法定标准，指定那些仍需遵守上市前通知要求的I类器械。FDA指定为豁免的器械不包括此前已通过法规豁免上市前通知要求的I类器械。该行动依据经1976年《医疗器械修正案》（1976年修正案）、1990年《安全医疗器械法案》（SMDA）及1997年《FDA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。FDA采取此行动是为了落实FDAMA的一项要求。在本期《联邦公报》的其他地方，FDA宣布将撤回撤销两种器械现有上市前通知豁免的拟议规则。
