The U.S. Food and Drug Administration (FDA) has received numerous inquiries regarding COVID-19 and its increasing impact on mammography facilities. On March 18, 2020, the FDA temporarily postponed domestic inspections as a result of the COVID-19 pandemic. The Agency has been monitoring and evaluating the situation to determine the best way and most appropriate time to resume routine inspections. The publication of the White House Guidelines for Opening Up America Again provides a roadmap for optimizing operations and new work arrangements. We continue to utilize these guidelines to develop a process to govern how and where to resume on-site inspections, when it’s safe to do so. As of June 17, 2020, our state regulatory partners that perform inspections under contract to the FDA may resume Mammography Quality Standards Act (MQSA) inspections. FDA expects that each state partner will defer to its state-specific COVID-19 response plans to determine when they will begin conducting inspections.
The FDA intends to issue guidance soon on inspection recommendations for mammography facilities during the COVID-19 pandemic. For any other inquiries, please contact the MQSA Hotline at 1-800-838-7715 or MQSAhotline@versatechinc.com.