Fed Regist. 1997 Dec 23;62(246):67011-3.
The Food and Drug Administration (FDA) is announcing its intention to review and, as necessary, to revise or to amend its compliance policy guides and regulatory requirements relating to the remarketing of used medical devices and the persons who refurbish, recondition, rebuild, service, or remarket such devices. The agency is considering these actions because it believes evolving industry practices warrant reevaluation of current policy and the application of certain regulatory requirements in order to ensure that particular remarketed devices meet suitable performance requirements for their intended uses, and are as safe as the originally marketed finished device. FDA is soliciting comments, proposals for alternative regulatory approaches, and information on these issues. In a future issue of the Federal Register, FDA will announce an open meeting of the Good Manufacturing Practices (GMP) Advisory Committee concerning these matters.
美国食品药品监督管理局（FDA）宣布，打算审查并在必要时修订或修正其合规政策指南以及与二手医疗设备再销售以及翻新、修复、重建、维修或再销售此类设备的人员相关的监管要求。该机构正在考虑采取这些行动，因为它认为行业惯例的不断演变有必要重新评估现行政策和某些监管要求的适用情况，以确保特定的再销售设备满足其预期用途的适当性能要求，并与最初上市的成品设备一样安全。FDA正在征求有关这些问题的意见、替代监管方法的建议以及相关信息。在未来一期的《联邦公报》中，FDA将宣布召开一次关于这些事项的良好生产规范（GMP）咨询委员会公开会议。
