A New Era for Device Quality Systems
In February 2024, FDA's updated Quality Management System Regulation (QMSR) took effect, replacing the legacy Quality System Regulation (QSR) under 21 CFR Part 820. The QMSR harmonizes FDA requirements with ISO 13485:2016, the international standard for medical device quality management.
The compliance date is February 2, 2026 — manufacturers must have their QMS updated by then.
Why the Change?
The previous 21 CFR Part 820 was last substantially updated in 1996. By aligning with ISO 13485:2016 — the globally recognized QMS standard — FDA aims to:
- Reduce duplicative compliance burdens for manufacturers selling in multiple markets
- Reflect modern quality system practices
- Harmonize with Health Canada, EU MDR, and other regulators that reference ISO 13485
Key Changes in the QMSR
1. ISO 13485 Becomes the Core
The QMSR incorporates ISO 13485:2016 by reference. Manufacturers must comply with ISO 13485 as the foundational QMS framework, supplemented by FDA-specific requirements.
2. Design and Development Planning
ISO 13485 places greater emphasis on risk management throughout design — specifically referencing ISO 14971 (Risk Management for Medical Devices). This is more explicit than the old QSR.
3. Supplier and Outsourced Process Controls
The QMSR strengthens requirements for monitoring and control of suppliers, requiring documented supplier evaluation and re-evaluation processes.
4. Complaint Handling and Feedback
ISO 13485 adds a formal feedback system requirement as part of post-market surveillance — going beyond complaint files to include proactive data gathering from the field.
5. Retained "FDA-Specific" Requirements
Despite the harmonization, FDA retained certain U.S.-specific requirements not in ISO 13485:
- Device History Record (DHR) — production records per device/lot
- Corrective and Preventive Action (CAPA) — still explicitly required
- Medical Device Reporting (MDR) — adverse event reporting obligations
What Manufacturers Should Do Now
- Gap assessment — compare your current QMS against ISO 13485:2016 requirements
- Update SOPs to reflect new terminology and structure
- Risk management integration — ensure ISO 14971 processes are documented throughout design
- Supplier controls — formalize evaluation and monitoring of critical suppliers
- Training — update staff training programs for the new requirements
How United Regulatory Can Help
We conduct QMSR gap assessments, update QMS documentation, and prepare your team for FDA inspections and MDSAP audits under the new framework. Contact us to start your QMSR transition today.