March 17, 2023

FDA Updates Mammography Regulations in MQSA Final Rule

The U.S. Food and Drug Administration (FDA) issued a final rule March 10 to update the mammography regulations issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). The American College of Radiology® (ACR®) continues to analyze the final rule and will release further information for providers and accredited facilities.

Noted during initial review, the final rule:

  • Updates addressing equipment and quality control to address current technology, including digital mammography.
  • Requires that mammograms submitted for interpretation be presented in the mammographic modality in which they were originally produced, and not be copied or digitized from hardcopy original images.
  • Prohibits accreditation bodies accepting an application for accreditation from a facility that has failed to become accredited after three consecutive attempts until one year after the most recent accreditation failure.
  • Expressly states that a facility’s certificate may be suspended or revoked due to a failure to comply with requests by FDA, the state certification agency, or the AB for records, including clinical images for an additional mammography review (AMR), or with requests by current or former facility personnel for records documenting their qualifications.
  • Clarifies that the state certification agency may initiate an AMR, which can help detect quality issues.
  • Expressly states that the FDA and the state certification agency can notify patients and their providers individually or through the mass media when a facility is unable or unwilling to perform a required patient and referring physician notification (PPN).
  • Requires facilities to provide personnel with copies of their MQSA qualification records, which are often needed to work at additional or new facilities.
  • Requires that the mammographic examination report include the facility name and location (at a minimum, the city, state, ZIP code and telephone number of the facility).
  • Revises explanatory language in the “benign” final assessment category and adds three new categories of mammographic assessment to the existing categories in the regulations.
  • Specifies timeframe for facilities to send mammography reports to healthcare providers and lay summaries to patients whose mammograms have either “Suspicious” or “Highly Suggestive of Malignancy” final assessment categories.
  • Requires inclusion of an assessment of breast density and specifies language that must be used in lay summaries and final reports to healthcare providers.
  • Requires that mammography facilities implement policies and procedures to minimize the loss of mammography images, specifying the timeframe within which facilities must transfer original mammograms and copies of reports to patients/healthcare providers.
  • Establishes requirements addressing medical audits, including clarification of the minimum information that facilities must collect as part of the mammography medical outcomes audit.

The rule is effective Sept. 10, 2024.

Members with questions can contact Gloria Romanelli, JD, ACR Senior Director, Legislative and Regulatory Relations.