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:
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:
QSIT vs. IMDMCP: Key Differences
QSIT
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:
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.
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
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
QSIT vs. IMDMCP: Key Differences
QSIT
- Subsystem-based inspection
- Procedure-focused
- Limited global alignment
- 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
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.
Feb 27,2026