GuidanceU.S. Food and Drug Administration / Federal Register · 2024 · 2 pp.
The FDA's official announcement that the Small Entity Compliance Guide (SECG) for the 2024 MQSA Final Rule is available. Published August 26, 2024, this Federal Register notice confirms the SECG as an FDA Level 2 guidance document — non-binding but representing the Agency's current thinking — intended to help mammography facilities, accreditation bodies, and certifying agencies comply with the MQSA regulations effective September 10, 2024.
Facility AdministratorLead Interpreting PhysicianTechnologistMedical Physicist
Read document →GuidanceU.S. Food and Drug Administration / Federal Register · 2023 · 46 pp.
The FDA's landmark 2024 update to MQSA regulations — the most significant revision in over 20 years. Published March 10, 2023 and effective September 10, 2024, this final rule mandates breast density notification in patient lay summaries, standardizes four BI-RADS density categories in mammography reports, strengthens the medical outcomes audit, and adds new enforcement tools for noncompliant facilities.
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Read document →ManualDoctrinaEdge Publishing · 2025 · 30 pp.
A practical manual guiding mammography facilities through the 2024 MQSA requirements effective September 10, 2024. Covers personnel qualifications, equipment QC, EQUIP, medical outcomes audits, patient communications including density notifications, recordkeeping, and a detailed inspection checklist. Emphasizes continuous readiness over one-time preparation.
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