Preparing for an MQSA Inspection
Annual inspections serve as the cornerstone of MQSA's quality assurance framework. Required by 42 U.S.C. 263b(g)(1)(E), these inspections FDA provide independent verification of facility compliance with quality standards, identify problems before patient harm occurs, ensure consistency of mammography quality nationwide, and maintain accountability in the accreditation-certification system.
The 2023 MQSA Final Rule (88 FR 15126), which became fully effective on September 10, 2024, represents the most comprehensive update to MQSA regulations since 1997. This modernization addressed technological advances including digital mammography and tomosynthesis, enhanced enforcement mechanisms, and established the nation's first mandatory breast density notification requirements.
As of 2024, approximately 250 FDA-trained and certified federal and state inspectors conduct these annual reviews across all mammography facilities in the United States.
Where Did It Go?
Have you been looking for guidance on getting ready for a MQSA inspection lately? Then, you might have noticed the FDA took their version from the early 2000's down from their website when the updated regulations went into effect on September 10, 2024.
After numerous questions and talking about it for a year, Mammologix has created its own version. It's FREE TO DOWNLOAD and includes everything you need to help you understand what an FDA/MQSA inspector is looking for based on updated regulations including an overview of the regulatory framework and organizational structure of MQSA. The Appendix contains twelve useful templates, tables, or information sources based on category.