publication date: Dec. 11, 2020
Drugs & Targets
FDA issues a guidance on quality standards of the Mammography Quality Standards Act during COVID-19
FDA is issuing a guidance on FDA’s enforcement policy regarding certain quality standards requirements under the Mammography Quality Standards Act of 1992.
The guidance is 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.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services on Jan. 31, 2020, effective Jan. 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).
This guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate.
This guidance document is being implemented immediately, but it remains subject to comment in accordance with FDA’s good guidance practices.
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