FDA Approves Alternative Standard to Address Incomplete Mammography Report Assessments

In response to concerns with the 2023 Amended MQSA Regulations regarding changes in the “Incomplete” assessment category, the U.S. Food and Drug Administration has approved Alternative Standard #25. This will allow practices to issue reports with the “Incomplete: Need additional imaging evaluation” in follow-up to an initial report with the Assessment “Incomplete: Need prior mammograms for comparison” assessment. The alternative standard allows the interpreting physician to update the assessment category once the comparison imaging is received. As written in the regulations effective Sept. 10, 2023, if an interpreting physician issued an “Incomplete: Need prior mammograms for comparison” assessment, they would have been required to issue a diagnostic assessment from a screening mammogram. If you have further questions please contact the MQSA Hotline.