Fed Regist. 1985 Nov 12;50(218):46646-7.
The Food and Drug Administration (FDA) is announcing the availability of a report prepared by the X-Ray Standard Review Group (XSRG) in FDA's Center for Devices and Radiological Health (CDRH). The report contains the review group's assessment of the performance standard for diagnostic x-ray systems and their major components. It contains recommendations for changes in the standard with respect to the need to ensure that regulatory controls keep pace with developing technology and the needs of the radiological community. In addition, FDA is inviting interested persons to submit written comments, data, or information regarding the report for the agency's consideration in deciding whether to initiate any changes in the performance standard.
美国食品药品监督管理局（FDA）宣布可获取由FDA设备与放射健康中心（CDRH）的X射线标准审查小组（XSRG）编写的一份报告。该报告包含审查小组对诊断X射线系统及其主要部件性能标准的评估。它包含了关于标准变更的建议，涉及确保监管控制跟上技术发展以及放射学界需求的必要性。此外，FDA邀请感兴趣的人士就该报告提交书面意见、数据或信息，以供该机构在决定是否对性能标准进行任何变更时参考。
