A new FDA requirement went into effect on Tuesday, September 10, requiring all mammography reports and result letters sent to patients in the United States to include an assessment of breast density.

The FDA issued a final rule on March 10, 2023, to amend the Mammography Quality Standards Act (MQSA) regulations (“2023 MQSA Final Rule”). Enforcement of the MQSA regulations as amended by the 2023 MQSA Final Rule began on September 10, 2024. Facilities subject to the MQSA, must now comply with all applicable requirements, including the breast density notification.

Access the 2023 MQSA Final Rule in its entirety at Federal Register: Mammography Quality Standards Act.

During a facility’s annual MQSA inspection, inspectors will review documentation that relates to whether the facility is meeting the requirements of the MQSA. As of September 10, 2024, the MQSA regulations have certain additional requirements, including:

Mammography Reports

  • Name and location of the facility performing the exam, (at a minimum the city, State, ZIP code, and telephone number).
  • An overall final assessment of findings, classified into one of the following categories:
    • Negative
    • Benign
    • Probably Benign
    • Suspicious
    • Highly Suggestive of Malignancy
    • Known-Biopsy-Proven Malignancy
    • Post-Procedure Mammogram for Marker Placement.
    • In cases where no final assessment category can be assigned due to incomplete work-up, the report should indicate:
      • Incomplete: Need additional imaging evaluation
      • Incomplete: Need prior mammograms for comparison.
  • An overall assessment of breast density, classified in one of the following categories:
    • “The breasts are almost entirely fatty.”
    • “There are scattered areas of fibroglandular density.”
    • “The breasts are heterogeneously dense, which may obscure small masses.”
    • “The breasts are extremely dense, which lowers the sensitivity of mammography.”

For more information and the list of additional requirements, click here.