Agency instructs imaging centers on possible closures and surveys.
Amid calls for all non-emergent imaging to be postponed during the COVID-19 outbreak, the U.S. Food & Drug Administration (FDA) announced additional guidance for breast imaging late last week.
“Protecting the health and safety of our staff and their families is of paramount concern to the U.S. Food & Drug Administration,” Commissioner Stephen Hahn, M.D., said in a statement. “As a nation, we must do everything we can to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic.”
On March 18, the FDA announced inspections for breast imaging facilities, including those contracted at the state level, would be suspended. In guidance, published March 19, the agency went further, detailing next steps for any imaging practices that choose to shut down during the crisis. The agency’s Division of Mammography Quality Standards announced it will offer “regulatory flexibility” for breast imaging providers facing various circumstances.
In its guidance, the FDA outlined three possible scenarios and how radiologists should respond:
The FDA said it will continue to monitor the situation as it unfolds and pointed anyone with questions to call 800-838-7715 or email MQSAhotline@versatechinc.com.