FDA’s QMSR – Key Update for Medical Device Manufacturers
The FDA had previously announced a major update to its quality system regulations for medical devices in 2024. The long-standing Quality System Regulation (QSR) will be replaced by the Quality Management System Regulation (QMSR). This change brings the FDA's rules in line with ISO 13485:2016, the global standard for medical device quality management system.
Why Is This Change Happening?
The main goal is harmonization. Many countries already follow ISO 13485, so by aligning with this standard, the FDA makes it easier for U.S. companies to sell products globally. It also improves efficiency, reduces duplicate work, and supports better patient safety.
The FDA's new QMSR rule was finalized in February 2024, and companies must comply by February 2, 2026.
What Does This Mean for Manufacturers?
If you manufacture or sell medical devices in the U.S., this rule affects you. Instead of following the older QSR, you'll now need to follow ISO 13485:2016, with some small FDA-specific additions. That means adjusting your quality management system (QMS) to meet these international standards.
While the core objective is alignment with international standards, there are key differences manufacturers must understand and prepare for:
1. Updated Terminology Aligned with ISO Standards
QMSR adopts much of the terminology from ISO 13485:2016, replacing terms that have long been foundational in QSR, such as Device Master Record (DMR), Device History Record (DHR), and Design History File (DHF). Although these terms will no longer appear in the regulation text, the underlying documentation requirements remain. Instead, manufacturers will be expected to maintain:
- Medical Device File
- Design and Development File
- Product Realization and Quality Records
The terminology shift reflects ISO's structure, but manufacturers are not required to rename existing documents. Internal references to DMR, DHR, and DHF may continue as long as the documentation meets the applicable requirements.
2. Formal Records Control Requirements
QMSR introduces a new section specifically dedicated to records control, reflecting the requirements of ISO 13485:2016 Clause 4.2.5. This section emphasizes the importance of accurate, accessible, and traceable records throughout the device lifecycle.
Notable additions include:
- The requirement is to include a unique device identifier (UDI), universal product code (UPC), or equivalent device identification in complaint and service records.
- Clarification that the UDI must be recorded for each unit or batch, supporting traceability and regulatory compliance.
- Confidentiality protection guidance: Manufacturers should clearly mark any proprietary documents as "confidential" when submitting to FDA, in alignment with FOIA and 21 CFR Part 20
3. Labeling and Packaging Controls Retained
While most QMSR provisions align with ISO 13485, the FDA has chosen to retain its existing requirements for labeling and packaging as they are considered more comprehensive.
Manufacturers must comply with:
- ISO 13485:2016 Clause 7.5.1, which addresses control of production and service provision
- QMSR Section 820.45, which reflects FDA-specific inspection and control measures for labeling and packaging operations
Where conflicts exist between ISO 13485 and QMSR, the FDA's regulation takes precedence.
4. Expanded Emphasis on Risk Management
Risk management is one of the most substantial areas of enhancement in QMSR. Under QSR, risk was only briefly addressed during design validation. QMSR, by adopting ISO 13485, requires integration of risk management throughout the entire quality system.
Manufacturers must now demonstrate risk-based decision making in:
- Design and development
- Purchasing and supplier controls
- Manufacturing processes
- Corrective and preventive actions (CAPA)
What Should Manufacturers Do Next?
The FDA's shift from QSR to QMSR is a major change, but it's a step in the right direction. It brings U.S. regulations in line with international standards and helps manufacturers streamline compliance. While change can be challenging, this update offers long-term benefits: better quality systems, simpler global compliance, and improved patient outcomes.
Now is the time to prepare. With just under a year left, early action will make for a smoother transition.