FDA Issues New Guidance on Mammography Equipment Inspections

The FDA has released new guidance aimed at easing inspection requirements for mammography equipment, acknowledging the challenges facing facilities during the COVID-19 pandemic.

The guidance states if a facility “temporarily ceased” conducting mammographies during the crisis, they may delay submission of the required annual survey by a medical physicist, but they must document the time period during which they were closed and present this information during an inspection.

For facilities that performed mammographies uninterrupted but have been unable to schedule a medical physicist survey, the FDA says they may also submit their annual surveys late, so long as they document the reasons why and present the information to the inspector.

In either case, the survey should be completed as soon as possible, ideally within six months of the 14-month date from the prior completed survey, the agency said.