The U.S. Food and Drug Administration (FDA) has received inquiries about the impact of COVID-19 on mammography facilities. On March 18, 2020, the FDA temporarily postponed domestic inspections as a result of the COVID-19 pandemic. On July 10, 2020, the FDA announced that prioritized domestic inspections were anticipated to resume with prioritization based on risk and other factors such as data about the virus' trajectory in a given state and locality and the rules and guidelines in place. Beginning July 1, 2021, the FDA transitioned to the Base-Case scenario (gradual transition to standard operations) as outlined in the Resiliency Roadmap for FDA Inspectional Oversight. Most Mammography Quality Standards Act (MQSA) inspections have resumed under this plan.
As of June 17, 2020, our state regulatory partners that perform inspections under contract to the FDA have resumed MQSA inspections. The FDA expects state partners to refer to their state-specific COVID-19 response plans when conducting inspections.
The FDA recognizes that many mammography facilities may have been impacted by unavoidable operational challenges as a result of the COVID-19 public health emergency. In response to common scenarios and challenges faced by mammography facilities in complying with MQSA quality standards (for example, the annual medical physicist survey and continuing education and experience) as a result of the COVID-19 public health emergency, the FDA has outlined our enforcement policy and general considerations for facilities in the guidance "Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency," which the FDA believes will help facilitate the availability of mammography services.
Facilities that continue to face difficulty in complying with the quality standards, including an inability to schedule a timely medical physicist survey as discussed further in the guidance, are encouraged to contact the MQSA Hotline at 1-800-838-7715 or MQSAhotline@versatechinc.com as soon as possible.
For inspection scheduling questions, contact your state agency or inspector if performed by the state, or the FDA district office or inspector if performed by the FDA. For questions regarding accreditation or accreditation body activities, contact your accreditation body. For any other inquiries, please contact the MQSA Hotline at 1-800-838-7715 or MQSAhotline@versatechinc.com.