Fed Regist. 1993 Sep 1;58(168):46514.
The Food and Drug Administration (FDA) is announcing an opportunity for public comments on the final rule on medical device distributor reporting, which is published elsewhere in this issue of the Federal Register. The medical device distributor reporting tentative final rule became final on May 28, 1992, by operation of the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments). Although not required to do so, FDA realizes that there may be issues not previously considered, such as technical issues on specific provisions, and therefore is providing this additional time for comment. If changes are warranted by comments, FDA will make further changes in the rules.
美国食品药品监督管理局（FDA）正在就医疗器械经销商报告的最终规则征求公众意见，该规则刊登在本期《联邦公报》的其他地方。医疗器械经销商报告暂行最终规则于1992年5月28日根据1990年《安全医疗器械法案》（SMDA）的规定成为最终规则，该法案经1992年《医疗器械修正案》（1992年修正案）修订。尽管没有要求这样做，但FDA意识到可能存在以前未考虑到的问题，例如特定条款的技术问题，因此提供了额外的时间征求意见。如果根据意见有必要进行修改，FDA将对规则进行进一步修改。
