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 routine inspections were anticipated to resume the week of July 20, 2020, with prioritization based on risk and other factors. However, resuming prioritized domestic routine inspections will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments. Due to the current risk assessment levels, no Mammography Quality Standards Act (MQSA) inspections are currently planned through July 31. For details on the resumption of domestic routine inspections in general, see Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic routine inspections with new risk assessment system.
As of June 17, 2020, our state regulatory partners that perform inspections under contract to the FDA may resume MQSA inspections. The FDA expects that state partners will refer to their state-specific COVID-19 response plans to determine when they will begin conducting inspections.
For inspection scheduling questions, contact your state agency/inspector if performed by the state, or the FDA district office or inspector if performed by the FDA. For any other inquiries, please contact the MQSA Hotline at 1-800-838-7715 or MQSAhotline@versatechinc.com.