Fed Regist. 1998 Feb 2;63(21):5387-93.
The Food and Drug Administration (FDA) is publishing a list of class I devices, subject to certain limitations, that will be exempt from premarket notification requirements on February 19, 1998. FDA is also publishing a list of those class I devices that FDA believes will remain subject to premarket notification requirements because they meet the new statutory criteria for premarket notification requirements. These lists do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. FDA is taking this action in order to meet a requirement of the Food and Drug Administration Modernization Act of 1997 (the FDAMA). The agency requests comments on whether the list of class I devices that will remain subject to the premarket notification requirements should be modified.
美国食品药品监督管理局（FDA）正在公布一份一类器械清单，在某些限制条件下，这些器械将免于1998年2月19日的上市前通知要求。FDA还公布了一份一类器械清单，FDA认为这些器械因符合上市前通知要求的新法定标准而仍需遵守上市前通知要求。这些清单不包括此前已根据法规免于上市前通知要求的一类器械。FDA采取这一行动是为了满足1997年《食品药品管理局现代化法案》（FDAMA）的一项要求。该机构就仍需遵守上市前通知要求的一类器械清单是否应修改征求意见。
