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优质乳腺钼靶摄影标准——美国食品药品监督管理局。最终规则。

Quality mammography standards--FDA. Final rule.

出版信息

Fed Regist. 1997 Oct 28;62(208):55852-994.

Abstract

The Food and Drug Administration (FDA) is amending its regulations governing mammography. Amendments are being made to the requirements for accreditation bodies; procedures for facility certification; and quality standards for mammography personnel, equipment and practices, including quality assurance. This action is being taken to provide increased assurance of adequate and consistent evaluation of mammography facilities on a nationwide level and compliance of the facilities with quality standards. It also carries out the intent of Congress that FDA replace the existing interim rules with more comprehensive final regulations.

摘要

美国食品药品监督管理局(FDA)正在修订其有关乳房X线摄影术的法规。此次修订涉及认证机构的要求、机构认证程序以及乳房X线摄影术人员、设备和操作(包括质量保证)的质量标准。采取这一行动是为了在全国范围内增强对乳房X线摄影术机构进行充分且一致评估的保障,并确保这些机构符合质量标准。这也贯彻了国会的意图,即FDA要用更全面的最终法规取代现有的临时规则。

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