Alternative Standards (MQSA)
FDA may approve an alternative to a quality standard under section 900.12 when the agency determines that the proposed alternative standard will be at least as effective in assuring quality mammography as the standard it proposes to replace and is too limited in its applicability to justify an amendment to the standard or offers an expected benefit to human health that is so great that the time required for amending the standard would present an unjustifiable risk to the human health.
Alternative Standards
- #1: Conducting the daily processor QC tests when the sensitometer is not available
- #2: Continuous display of the override status for machines with decompression devices
- #3: Conducting the weekly phantom image test at facilities with intermittent mammography operation
- #4: Post exposure indication of the machine pre-selected focal spot and or target material
- #5: Verification Testing After Certain Modifications of the AEC of Senographe(TM) 700T, 800T, DMR Mammography Systems
- #6: Conducting the Mammography Equipment Evaluation After a Software Upgrade Under Medical Physicist Oversight
- #7: Combined Mammography Medical Outcomes Audit for Multiple Mobile Mammography Units
- #8: Separate Assessment of Findings For Each Breast
- #9: Correction Period When Components of the Selenia Full Field Digital Mammography System, the Selenia Dimensions 2D Full Field Digital Mammography system and the Selenia Dimensions 3D/ Digital Breast Tomosynthesis system Fail Quality Control Tests
- #10: Amendment to the Alternative Requirement for the Correction Period When Components of the Senographe(TM) 2000D Full Field Digital Mammography (FFDM) System Fail Quality Control Tests
- #11: Modifications in the Assessment Categories Used in Medical Reports
- #12: Assessment category for "Post Procedure Mammograms for Marker Placement"
- #13: System Artifact Testing at Remote Mobile Mammography Sites Where Film Processing Takes Place Using Processors Permanently Located at the Site
- #14: System Artifact Testing of Target Filter Combinations
- #15: Corrective Action Period When Components of the Fuji Computed Radiography for Mammography (FCRm) Full Field Digital Mammography (FFDM) System Fail Quality Control Tests
- #16: Approval of an alternative standard to the Medical Outcomes Audit requirement that allows multiple stationary mammography facilities to combine their medical outcomes audits
- #17: Correction Period When Components of the Siemens Mammomat Novation Full Field Digital Mammography System Fail Quality Control Tests
- #18: Approval of an Alternative Standard indicating time periods allowed for corrective actions following the failure of specified quality control tests for the Carestream DirectView CR Mammography Feature Full Field Digital Mammography imaging system
- #19: Correction Period When Components of the Sectra MicroDose L30 Full Field Digital Mammography Imaging System Fail Quality Control Tests
- #20: Correction Period When Components of the Planmed Nuance and Nuance Excel Full Field Digital Mammography Imaging System Fail Quality Control Tests
- #21: Correction Period When Components of the Agfa CR Full Field Digital Mammography Imaging System Fail Quality Control Tests
- #22: Correction Period When Components of the Giotto Image 3D-3DL Full Field Digital Mammography Imaging System Fail Quality Control Tests
- #23: Correction Period When Components of the Fuji Aspire HD, Aspire HD Plus and Aspire HD-s Full Field Digital Mammography imaging systems Full Field Digital Mammography imaging systems Fail Quality Control Tests
- #24: Approval of an Alternative Standard for Using the Quality Assurance Program Recommended by the ACR Digital Mammography Quality Control Manual for Full-Field Digital Mammography Systems and Supplement for Digital Breast Tomosynthesis Mammography Systems