The U.S. Food and Drug Administration Requires Notification of Breast Density in Mammography Reports

  • Practice Advisory PA
  • April 2023

This Practice Advisory was developed by the American College of Obstetricians and Gynecologists.

This Practice Advisory serves as an update to Committee Opinion No. 625, Management of Women With Dense Breasts Diagnosed by Mammography (originally published in 2015) 1 .

On March 9, 2023, the U.S. Food and Drug Administration (FDA) released a final rule updating mammography regulations issued under the Mammography Quality Standards Act of 1992 and the Federal Food, Drug, and Cosmetic Act 2 . In addition to other updates, the new FDA rule requires breast density reporting be included in both 1) the mammography reports provided to clinicians and 2) the lay language summaries provided to patients. The written report provided to clinicians will include an overall assessment of breast density classified into one of the following categories: A) “The breasts are almost entirely fatty”; B) “There are scattered areas of fibroglandular density”; C) “The breasts are heterogeneously dense, which may obscure small masses”; and D) “The breasts are extremely dense, which lowers the sensitivity of mammography.” For the patient notification, the FDA has collapsed the four BI-RADS categories of breast density into two: either “dense” or “not dense.” The patient report will include an FDA-developed prescribed paragraph on the significance of breast density. The full rule can be accessed online at

Based on the lack of data demonstrating a clear benefit, the American College of Obstetricians and Gynecologists (ACOG) currently does not recommend the routine use of alternative or adjunctive tests to screening mammography in individuals with dense breasts who are asymptomatic and have no additional risk factors 1 . More research is needed to identify more effective screening methods that will enhance meaningful improvements in cancer outcomes for those with dense breasts and minimize false-positive screening results.

Updated ACOG Recommendation

While ACOG does not recommend routine use of alternative or adjunctive tests to screening mammography in individuals with dense breasts who are asymptomatic and have no additional risk factors, ACOG recommends that clinicians comply with the new FDA rule and any state laws and federal rules that require disclosure of a patient’s breast density as recorded in a mammogram report.

ACOG’s clinical guidance is routinely reviewed for accuracy and potential updates. Any new guidance will be published online and in Obstetrics & Gynecology. Please contact [email protected] with any questions.


  1. Management of women with dense breasts diagnosed by mammography. Committee Opinion No. 625. American College of Obstetricians and Gynecologists [published erratum appears in Obstet Gynecol 2016;127:166]. Obstet Gynecol 2015;125:750-1. doi: 10.1097/01.AOG.0000461763.77781.79
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  2. Mammography Quality Standards Act. Final rule. Department of Health and Human Services, Food and Drug Administration. Fed Regist 2023;88:15126-71. Accessed March 10, 2023. Available at:
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