Final Rule Amends Mammography Regulations to Improve Quality Care of Women

Breast Cancer is the second leading cause of cancer-related deaths in women. The average risk of a woman in the US developing breast cancer in her life is 13 % (1 in 8 chance). Increased awareness, early screening, and better treatments have contributed to the decline of breast cancer deaths by 43% since 1989. The Mammography Quality Standards Act(MQSA)passed by Congress in 1992, helped lead the charge in early breast cancer detection by requiring breast imaging facilities to provide uniform, quality mammographs. This law allows the FDA to oversee mammography facility accreditation, certification, annual inspections, and enforcement standards.

About three decades later, the FDA’s commitment to helping “prevent, detect, and treat [breast] cancer” continues by introducing the Final Rule. This amendment is meant to update the regulations to current mammography breast practices to improve cancer detection. 

Major provisions listed in the Final Rule include:

  1. Changes in mammography technology (e.g., digital mammography)
  2. Enhance enforcement of Quality Standards
  3. Improvements in the way mammography results are categorized, reported, retained, and transferred to patients and healthcare providers

The third provision will require facilities to provide information about breast density to their patients in simple language, explaining how breast density can impact mammography accuracy. This aims to empower patients to make informed decisions about their breast health care. 

There has been opposition to the provisions, including the breast density notification requirement. Critics argue that the patients cannot interpret the results, which would only cause increased anxiety and a more significant burden on the healthcare provider. Though, the FDA has emphasized that these new requirements provide an opportunity to enhance communication between the patient and healthcare providers. Additionally, 38 states have already passed laws mandating breast density notification. Therefore, this requirement will provide more uniform quality care to all patients.

The exclusion of other imaging modalities in the Final Rule has been questioned. Ultrasound, the method used to screen for cancers that are not mammographically visible, is not included in the provisions. The FDA does not seek to include other modalities that might be more effective than mammography not to overwhelm the patients.

These modernized regulations are expected to take effect in 18 months. Do you agree with the FDA under the Final Rule to report breast density to patients? Digital Breast Tomosynthesis (DBT), included in the Final Rule, is considered supplemental to conventional mammography. How can the notification wording be standardized to eliminate patient confusion and prevent overwhelming health providers from requesting additional ultrasound screenings or DBTs?


Related content

  • The Hidden Costs of Reliability Failures

  • EUA – Recommended Submission Information