FDA QMSR vs. ISO 13485: Why “Alignment” Doesn’t Mean “Identical”

Key Takeaways 

• The Change: The FDA is replacing the legacy 21 CFR 820 with the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference.
• Terminology: Familiar terms like DHF, DMR, and DHR are being retired in favor of ISO-equivalent terms, though the documentation requirements remain just as rigorous.
• What is Needed: Compliance with ISO 13485 alone is not enough. The FDA has retained specific requirements for UDI, labeling, and MDR reporting.
• Timing: Manufacturers have until February 2, 2026 to ensure their quality system is compliant with the new QMSR standards.

For the first time in over 25 years, the FDA has fundamentally rewritten the rules for medical device quality management. By shifting from the legacy Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), the FDA is harmonizing U.S. standards with international expectations (ISO 13485:2016).

Ideally, this will be good for startups looking to scale globally. However, many founders may be under the impression that "harmonized" means "the same". It doesn't. Understanding the gaps is critical to ensuring compliance.

1.  Structural Evolution: From Subparts to ISO Clauses

The most immediate change is structural. The old QSR was organized into subparts (A through O). The new QMSR largely discards this in favor of the framework used by ISO 13485:2016.

While this simplifies procedures for companies selling in countries that require ISO 13485 compliance, it requires a complete re-mapping of your Quality Manual. Your internal procedures and regulatory citations must now reflect this new structure to remain compliant with the FDA’s Final Rule. 

2.  The Terminology: DHF and DMR are No Longer Explicitly Defined

One of the biggest hurdles for engineering teams is the shift in terminology. The familiar acronyms—Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) are no longer explicitly defined in the QMSR. Instead, the FDA expects manufacturers to use ISO 13485 equivalents, such as the Design and Development File and the Medical Device File.

Looking Closer: Don't let the lack of a "DHF" label fool you. The underlying requirement to document the evolution of your device remains. We suggest maintaining a cross-reference map during this transition to ensure your legacy data remains accessible during an inspection. 

3.  Operational Shifts: The "FDA-Plus" Requirements

The FDA requirements have not been completely replaced by ISO. The QMSR includes "supplemental" requirements that go beyond the standard ISO 13485 requirements. We call this the "FDA-Plus" approach. Key areas where the FDA retains its specific input include:

• Labeling & Packaging: Specific controls for labeling inspection remain in place.
• Unique Device Identification (UDI): FDA-specific UDI requirements are still mandatory.
• Reporting: Requirements for Medical Device Reporting (MDR) and corrections/removals are not replaced by ISO standards. 

4.  Risk Management is No Longer Optional

While ISO 13485 has always been risk-centric, the new QMSR places a much heavier emphasis on a risk-based approach throughout the entire Quality Management System (QMS). This impacts everything from supplier controls to how you handle Corrective and Preventive Actions (CAPA). 

Is Your QMS Ready for 2026?

Performing a comprehensive gap assessment of your QMS against the new QMSR is essential to ensure compliance readiness. As a full product development lifecycle partner, Kapstone Medical integrates development, manufacturing, and regulatory expertise to ensure your transition to QMSR is seamless.

Don't wait until after the February 2026 deadline to find the gaps in your system.

Would you like Kapstone’s experts to conduct a QMSR Gap Analysis for your company? Contact our Quality Team today.