Fed Regist. 1993 Aug 16;58(156):43451-5.
The Food and Drug Administration (FDA) is amending the medical device tracking regulations to add the temporo-mandibular joint prostheses to the illustrative list of devices and the penile inflatable implant to the list of devices designated for tracking. These devices are being added to the illustrative and designated device lists based on the significance of the risk to health posed by their use. This action requires manufacturers to track these devices after distribution so that they can be located in the event of a recall or patient notification action. FDA requests comments on these changes. Elsewhere in this issue of the Federal Register, the agency is announcing notification of the change of status of the device tracking regulations and is suspending the effective date of the regulations until August 29, 1993.
美国食品药品监督管理局（FDA）正在修订医疗器械追踪法规，将颞下颌关节假体添加到器械示例清单中，并将阴茎可充气植入物添加到指定追踪的器械清单中。基于这些器械使用对健康造成风险的严重性，它们被添加到示例和指定器械清单中。此行动要求制造商在器械分发后对其进行追踪，以便在召回或患者通知行动时能够找到它们。FDA就这些变更征求意见。在本期《联邦公报》的其他地方，该机构正在宣布器械追踪法规状态变更的通知，并将法规的生效日期暂停至1993年8月29日。
