Goodbye QSIT: Welcome FDA’s Inspection of Medical Device Manufacturers Compliance Program
Goodbye QSIT: Welcome FDA’s Inspection of Medical Device Manufacturers Compliance Program
The U.S. Food and Drug Administration (FDA) has officially replaced QSIT (Quality System Inspection Technique) with the Inspection of Medical Device Manufacturers Compliance Program (IMDMCP).
For medical device manufacturers, this change significantly impacts how FDA inspections are conducted in 2026 and beyond.
Why Did FDA Replace QSIT?
QSIT had been used since 1999 to inspect compliance with 21 CFR Part 820. However, the regulatory landscape has evolved. The FDA is modernizing its approach to:
Align with ISO 13485
Support the new Quality Management System Regulation (QMSR)
Focus more on risk-based inspections
Improve global harmonization
The result: a more comprehensive and flexible inspection model.
What Is the Inspection of Medical Device Manufacturers Compliance Program?
The IMDMCP is FDA’s updated framework for evaluating medical device manufacturers’ quality management systems.
Instead of reviewing subsystems individually (like QSIT), FDA inspectors now assess:
Overall Quality Management System (QMS) effectiveness
Risk management integration
Management responsibility
Supplier controls
Post-market surveillance
This means inspections are now more holistic and risk-driven. QSIT vs. IMDMCP: Key Differences QSIT
Subsystem-based inspection
Procedure-focused
Limited global alignment
IMDMCP
Full QMS evaluation
Risk-based approach
Aligned with ISO 13485 & QMSR
Greater management accountability
What This Means for Medical Device Companies
If you manufacture medical devices, expect: ✔ Stronger focus on risk management
✔ Increased scrutiny of leadership involvement
✔ Deeper review of supplier controls
✔ Lifecycle-based compliance evaluation Simply passing a QSIT-style mock audit is no longer enough. How to Prepare for FDA’s New Inspection Approach
To stay inspection-ready:
Conduct a gap analysis against ISO 13485
Strengthen your risk management documentation
Review CAPA effectiveness
Ensure management reviews are robust
Update internal audit programs
Proactive companies that align early will face fewer surprises during FDA inspections.
Final Takeaway
“Goodbye QSIT” is more than a headline — it represents FDA’s shift toward a modern, globally aligned, risk-based inspection system.
The Inspection of Medical Device Manufacturers Compliance Program sets a higher expectation for quality management system maturity.
Manufacturers who adapt now will be better positioned for FDA inspections in 2026 and beyond.
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