FDA Official Alignment with ISO 13485

The FDA has officially aligned its Quality System Regulation (QSR) with ISO 13485:2016 to promote global harmonization in medical device regulation.

On January 31, 2024, the FDA issued its final rule updating the Quality System Regulation (21 CFR Part 820), now renamed the Quality Management System Regulation (QMSR). This update incorporates ISO 13485:2016 by reference, marking a significant shift toward international regulatory alignment.

The rule is effective two years after publication in the Federal Register. Until then manufacturers are required to comply with the QS regulation. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.

The QMSR gives the FDA the authority to inspect management review, quality audits, and supplier audit reports.

FDA will have a new inspection process to align with the requirements of the Quality Management System Regulation (QMSR).

FDA inspections under the QMSR will not follow the MDSAP audit plan or procedures. The FDA will not require certificates of conformance to ISO 13485 and will not issue certificates of conformance to ISO 13485. A certificate of conformance to ISO 13485 will not exempt a manufacturer from an FDA inspection. 

🔍 Key Highlights

• ISO 13485:2016 Integration: The QMSR now mirrors the internationally recognized standard for medical device quality management systems, used by regulators in the EU, Canada, Australia, and more.
• Risk Management Emphasis: The new regulation explicitly integrates risk-based decision-making and lifecycle risk management, consistent with ISO 13485 principles.
• Global Harmonization: This move reduces regulatory burden for manufacturers operating in multiple markets and supports consistent product quality and safety worldwide.
• FDA Inspections: While ISO 13485 compliance is now central, FDA retains authority to inspect for specific U.S. requirements not covered by the standard.