FDA Approves Alternative Standard to Address Incomplete Mammography Report Assessments
In response to concerns with the regarding changes in the “Incomplete” assessment category, the U.S. Food and Drug Administration has approved . 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 .