FDA Publishes New Quality Management System Regulation (QMSR) and Transforms the Regulatory Landscape for Medical Devices
The U.S. Food and Drug Administration (FDA) has published the Quality Management System Regulation (QMSR), a significant update to the former Quality System Regulation (QSR) found in 21 CFR Part 820. This new regulation will come into effect on February 2, 2026, and represents one of the biggest regulatory advancements in medical device quality management in recent decades.
The QMSR incorporates by reference the international standard ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes, as well as selected clauses from ISO 9000:2015 – Quality management systems – Fundamentals and vocabulary. This incorporation approach enhances harmonization between the U.S. regulatory system and international standards, promoting greater consistency, reducing regulatory barriers, and aligning with globally recognized quality management practices.
Among the main changes, a more explicit integration of risk management concepts throughout the entire product lifecycle stands out – something that was less detailed in the old QSR – and which is now a central requirement under the QMSR framework. This means that manufacturers will need to demonstrate that risk processes, monitoring, continuous improvement, and compliance are effectively integrated into the quality management system.
For international and national manufacturers wishing to commercialize medical devices in the U.S., the new QMSR reinforces the need for compliance reviews, gap analyses, and eventual updating of procedures, data, and technical documentation based on the requirements of ISO 13485:2016.
Furthermore, the FDA has ceased using the old “Quality System Inspection Technique (QSIT)” and adopted a new inspection model aligned with QMSR, reflecting the agency’s commitment to modern oversight and quality assurance practices.
Passarini Group is prepared to support medical device companies in this regulatory transition, offering compliance analysis services, adaptation of quality management systems, and personalized technical-regulatory support to meet the new FDA requirements.
Contact us to learn more about our services and how we can facilitate your sales in Brazil. Reach out to us at contato@passarini.com.br
