What is changing under FDA QMSR?
On February 2, 2024, the US FDA finalized a landmark update to its quality system requirements, officially aligning its regulations with ISO 13485:2016. This update replaces the long-standing Quality System Regulation (QSR) under 21 CFR Part 820 with the new Quality Management System Regulation (QMSR). QMSR is set to take effect on February 2, 2026 and represents the most significant change to FDA’s quality management framework in over 25 years. Device manufacturers selling in the US will need to update their quality management systems to meet these harmonized requirements well ahead of the deadline.
FDA maintains that QMSR is not fundamentally different from the current rules. The most significant change is QMSR’s stronger focus on life cycle risk management by fully integrating the risk-based approach of ISO 13485:2016. Manufacturers will need to adopt more comprehensive risk controls covering everything from supplier oversight to software validation.
More granular QMSR changes include:
- Enhanced labeling and packaging controls
- Additional unique device identification (UDI) and traceability requirements
- Increased recordkeeping and confidentiality
- Design control updates
- Terminology changes
- Clearer QMS requirements for combination products
FDA will also roll out a new inspection model that aligns with the updated QMSR framework. Plans for the new inspection model have not been announced, but are expected to mirror ISO 13485 certification inspections. The scope of inspections may widen to include documents previously outside of FDA review.
Preparing for the FDA QMSR Deadline
QMSR implementation is not a significant life for manufacturers with a QSR-compliant QMS or ISO 13485 certification. However, companies not familiar with ISO 13485:2016, its terminology, or audit processes, may have more gaps to address.
Companies with ISO 13485:2016 certification are ahead of the game, but your certification alone does not guarantee full compliance with QMSR, nor does it exempt you from FDA inspections. You will still need to review your quality management system carefully to address any differences and be fully ready for the new inspection processes under QMSR.
