Fed Regist. 1992 May 29;57(104):22966-70.
The Food and Drug Administration (FDA) is issuing a final rule to establish a device tracking requirement for certain categories of medical devices as required by the Safe Medical Devices Act of 1990 (the SMDA). In a proposed rule issued on May 27, 1992, and published elsewhere in this issue of the Federal Register, FDA discussed the agency's initial review of certain comments received in response to an earlier proposed rule that published in the Federal Register of March 27, 1992 (57 FR 10702), that has been withdrawn. In issuing this final rule, FDA is providing notice that the proposed rule published elsewhere in this issue of the Federal Register now has the status of a final rule by operation of section 3(c)(2) of the SMDA. FDA is also confirming that the effective date of this rule is March 1, 1993. This rule applies to all devices subject to tracking under the SMDA that are initially introduced into interstate commerce or presented for importation into the United States on or after March 1, 1993. In the proposed rule published elsewhere in this issue of the Federal Register, FDA requests comments on that proposal. Upon closure of the comment period for that proposed rule and consideration of comments responding to both the original March 27, 1992, proposed rule and the new proposed rule, FDA will, if necessary, take further actions to revise the rule.
美国食品药品监督管理局（FDA）正在发布一项最终规则，以按照1990年《安全医疗器械法案》（SMDA）的要求，对某些类别的医疗器械建立器械追踪规定。在1992年5月27日发布并刊登在本期《联邦公报》其他地方的一项拟议规则中，FDA讨论了该机构对针对1992年3月27日在《联邦公报》上发布（57 FR 10702）但已撤回的较早拟议规则所收到的某些评论的初步审查情况。在发布这项最终规则时，FDA特此通知，刊登在本期《联邦公报》其他地方的拟议规则现因SMDA第3(c)(2)条的运作而具有最终规则的地位。FDA还确认本规则的生效日期为1993年3月1日。本规则适用于根据SMDA须进行追踪且于1993年3月1日或之后首次进入州际商业流通或提交进口到美国的所有器械。在刊登在本期《联邦公报》其他地方的拟议规则中，FDA就该提案征求意见。在该拟议规则的意见征求期结束并考虑了对1992年3月27日的原始拟议规则和新拟议规则的回复意见后，FDA如有必要将采取进一步行动对该规则进行修订。
