FDA Issues Guidance on Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act

December 4, 2020 — Today, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance, Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency. This guidance provides the FDA’s enforcement policy and general considerations in response to common scenarios faced by mammography facilities as a result of the COVID-19 public health emergency. 

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.

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 (HHS) on January 31, 2020, effective January 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)).

Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled "Process for Making Available Guidance Documents Related to Coronavirus Disease 2019," 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 (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices.

Download the final guidance document here.