FDA approves updated standard related to breast density reporting
The U.S. Food and Drug Administration has approved an update to breast density reporting at the urging of the American College of Radiology.
ACR said it first made the request on June 23. It allows interpreting physicians to provide an assessment of breast tissue using “singular phrasing” in reports of unilateral mammograms.
The original standard let radiologists classify density into categories such as “the breasts are almost entirely fatty.”
However, following the July 11 FDA approval, “Alternative Standard #26” allows rads the option of reporting “the breast is almost entirely fatty,” using singular phrasing.
The FDA announced the update on July 25, noting it takes effect immediately. Reporting physicians also have the option of using phrasing that is “neither singular nor plural.”
“We are happy that the FDA approved ACR’s request for an alternative standard as this will allow interpreting physicians the opportunity to provide information that is clinically relevant to each individual patient,” Stamatia V. Destounis, MD, chair of ACR’s Commission on Breast Imaging, said in a July 16 news update from the college.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.