FDA Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency

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Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency[附网盘链接]由FDA于过去发布,适用于美国。

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Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency[附网盘链接]
Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency[附网盘链接](截图)

 

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标准文档类型为Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency[附网盘链接]高清PDF版本(文字版),标准文档内可进行搜索,可以复制原文,可粘贴。

标准部分原文

Contains Nonbinding Recommendations Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency Guidance for Mammography Facilities, State MQSA Contract Partners, FDA-Approved Accreditation Bodies, and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide FDA’s enforcement policy regarding certain quality standards requirements under the Mammography Quality Standards Act of 1992 (MQSA) and also to provide general considerations to facilities that may have temporarily ceased performing mammography or that may be continuing to perform mammography while facing difficulty in complying with certain quality standards requirements during the public health emergency. The MQSA is part of United States Code Title 42 – Public Health and Welfare, and is implemented in FDA’s regulations at 21 CFR part 900. 4

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