FDA Offers Additional Guidance for Breast Imaging Centers During COVID-19

March 23, 2020

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:

  • If a facility is forced to close during the COVID-19 outbreak, it should document the dates during which it wasn’t performing mammography and ensure any required quality testing is completed upon re-opening. This includes yearly physicist surveys, as well as any other quality-assurance duties needed during the closure.

  • If practices cannot reschedule an annual medical physicist survey due to travel restrictions or other circumstances beyond their control, they should contact the FDA or state agency for an extension. This action is only necessary, however, if the inspection will be conducted beyond 14 months. Written requests for a delay must be submitted before reaching that anniversary.

  • Providers that choose to stay open, but that have non-compliance citations due to circumstances beyond their control, must keep detailed documentation, including imaging personnel failing to complete continuing education requirements because of travel or course cancellations, or practices not being able to fulfill Enhancing Quality Using the Inspection Program (EQUIP) requirements because of COVID-19-related staff absences.

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.