Fed Regist. 2002 Feb 6;67(25):5446-69.
The Food and Drug Administration (FDA) is amending its regulations governing mammography. The amendments implement the "States as Certifiers" (SAC) provisions of the Mammography Quality Standards Act of 1992 (MQSA). These amendments permit FDA to authorize individual States to certify mammography facilities, conduct facility inspections, enforce the MQSA quality standards, and administer other related functions. The amendments establish the standards to be met by States receiving this authority. They also establish procedures for application, approval, evaluation, and withdrawal of approval of States as certification agencies. FDA retains oversight responsibility for the activities of the States to which this authority is given. Mammography facilities certified by those States must continue to meet the quality standards established by FDA for mammography facilities nationwide.
美国食品药品监督管理局（FDA）正在修订其有关乳房X光检查的规定。这些修订实施了1992年《乳房X光检查质量标准法案》（MQSA）中的“州作为认证机构”（SAC）条款。这些修订允许FDA授权个别州对乳房X光检查设施进行认证、开展设施检查、执行MQSA质量标准并履行其他相关职能。修订案规定了获得此项授权的州需满足的标准。它们还确立了州作为认证机构的申请、批准、评估及批准撤销程序。FDA对获得此项授权的州的活动保留监督责任。由这些州认证的乳房X光检查设施必须继续符合FDA为全国乳房X光检查设施制定的质量标准。
