News | Mammography | December 04, 2020

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

Guidance for mammography facilities, state MQSA contract partners, FDA-approved MQSA accreditation bodies and Food and Drug Administration staff

Guidance for mammography facilities, state MQSA contract partners, FDA-approved MQSA accreditation bodies and Food and Drug Administration staff

Getty Images

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.

Related Content

3D aMRI not only provides a stunning look inside the "beating brain", but it can also measure this physiological motion in all directions. Here, the amplitude of brain motion is overlayed for each brain slice and orientation in 3D. Image credit: 3D aMRI method outlined in Abderezaei et al. Brain Multiphysics (2021); Terem et al. Magnetic Resonance in Medicine (2021).

3D aMRI not only provides a stunning look inside the "beating brain", but it can also measure this physiological motion in all directions. Here, the amplitude of brain motion is overlayed for each brain slice and orientation in 3D. Image credit: 3D aMRI method outlined in Abderezaei et al. Brain Multiphysics (2021); Terem et al. Magnetic Resonance in Medicine (2021).

News | Magnetic Resonance Imaging (MRI) | May 06, 2021
May 6, 2021 — Magnetic Resonance Imaging
Research finds that a commonly used risk-prediction model for lung cancer does not accurately identify high-risk Black patients who could benefit from early screening

Getty Images

News | Lung Imaging | May 05, 2021
May 5, 2021 — Lung cancer is the third most common cance
After radiosurgery concurrent with nivolumab in 59-year-old patient with melanoma BM (patient 1; Supplemental Tables 3 and 5), F-18 FET PET at follow-up 12 weeks after treatment initiation (bottom row) shows significant decrease of metabolic activity (TBRmean, ?28%) compared with baseline (top row), although MRI changes were consistent with progression according to iRANO criteria. Reduction of metabolic activity was associated with stable clinical course over 10 mo. CE = contrast-enhanced. Image created by

After radiosurgery concurrent with nivolumab in 59-year-old patient with melanoma BM (patient 1; Supplemental Tables 3 and 5), F-18 FET PET at follow-up 12 weeks after treatment initiation (bottom row) shows significant decrease of metabolic activity (TBRmean, ?28%) compared with baseline (top row), although MRI changes were consistent with progression according to iRANO criteria. Reduction of metabolic activity was associated with stable clinical course over 10 mo. CE = contrast-enhanced. Image created by N. Galldiks et al., Research Center Juelich, Juelich, Germany.

News | PET Imaging | May 05, 2021
May 5, 2021 — For patients with brain metastases, amino acid ...
When working with a vendor on project implementation, it is critical to focus on the actual execution of the implementation

Getty Images

Feature | Radiology Business | May 05, 2021 | By Jef Williams
You have selected a vendor. Congratulations.
Building the right infrastructure today will ensure the needed tools are there tomorrow, whatever the challenge may be

Getty Images

Feature | Radiology Business | May 05, 2021 | By Tom Cheesewrite in collaboration with Ludger Philippsen
The COVID-19 pandemic came as a shock, but not a