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Mammography Quality Standards: Requirements for Facilities, Personnel, Equipment, and Reporting

This guidance provides detailed information for mammography facilities to comply with the Mammography Quality Standards Act (MQSA) and its implementing regulations, with a focus on the amendments that become effective September 10, 2024. It covers requirements for certification, accreditation, inspections, personnel qualifications, equipment standards, quality control, medical outcomes audit, recordkeeping, and reporting of results to patients and healthcare providers.

  1. Review and update facility policies and procedures to comply with new requirements effective September 10, 2024
  2. Implement required breast density reporting language in mammography reports and lay summaries
  3. Establish medical outcomes audit procedures including the three required metrics
  4. Update recordkeeping systems to maintain required documentation
  5. Ensure personnel meet qualification and continuing education requirements
  6. Implement quality control program according to manufacturer specifications or approved alternative standards
  7. Establish procedures for patient notification and records access
  8. Prepare for annual MQSA inspections by organizing required documentation
  9. Subscribe to FDA MQSA updates to stay informed of requirements
  10. Contact MQSA Hotline for clarification of requirements as needed

Key Considerations

Clinical testing

  • Medical outcomes audit must include positive predictive value, cancer detection rate, and recall rate calculations
  • Follow-up required on all positive mammograms and known breast cancer cases
  • Correlation of pathology results with mammography reports required

Non-clinical testing

  • Equipment performance testing through annual surveys and mammography equipment evaluations required
  • Quality control testing according to manufacturer specifications or approved alternative standards
  • Phantom image testing during inspections

Human Factors

  • Personnel qualifications and continuing education requirements for interpreting physicians, radiologic technologists, and medical physicists
  • Direct supervision requirements for training
  • Documentation of training and experience records

Software

  • Software must meet FDA premarket authorization requirements
  • Quality control requirements apply to remote review workstations
  • Lossy compression not allowed for image storage

Labelling

  • Specific breast density notification language required in reports and lay summaries
  • Required elements for mammography reports and lay summaries
  • Timeframes for communicating results to patients and providers

Safety

  • Maximum dose limits for mammography exposures
  • Equipment performance standards
  • Quality control program requirements

Other considerations

  • 21 CFR Part 900: Mammography Quality Standards
  • 42 U.S.C. 263b: Mammography Facilities

Original guidance

  • Mammography Quality Standards: Requirements for Facilities, Personnel, Equipment, and Reporting
  • HTML / PDF
  • Issue date: 2024-08-26
  • Last changed date: 2024-08-23
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: 40d5d7e83216b78bdb27831c479158d2
This post is licensed under CC BY 4.0 by the author.