Fed Regist. 1994 Sep 30;59(189):49808-13.
The Food and Drug Administration (FDA) is issuing regulations to implement the Mammography Quality Standards Act of 1992 (MQSA). The MQSA requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accrediting bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. This regulation, which amends two previously published interim rules, modifies and adds to the definitions previously set forth. In addition, the interim rule provides a mechanism to request permission to meet alternative requirements, other than those previously set forth, if the proposed alternative requirement is at least as effective as the existing quality standards in achieving quality mammography services for women.
美国食品药品监督管理局（FDA）正在发布法规，以实施1992年的《乳房X线摄影质量标准法案》（MQSA）。MQSA要求为乳房X线摄影设施建立联邦认证和检查计划；为乳房X线摄影设施的认证机构制定法规和标准；以及制定乳房X线摄影设备、人员和操作的标准，包括质量保证。本法规修订了之前发布的两项暂行规则，对先前规定的定义进行了修改和补充。此外，暂行规则提供了一种机制，即如果提议的替代要求在为女性提供高质量乳房X线摄影服务方面至少与现有质量标准一样有效，则可请求允许满足这些替代要求，而非先前规定的要求。
