QMSR-Related FDA Regulations and International Standards

QMSR-Related Regulations and Standards

The transition from the FDA’s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) marks a significant shift in how medical device manufacturers align with global quality standards.

This page provides a comprehensive list of key FDA regulations and international standards that are essential for understanding and implementing the new QMSR framework. With the FDA now harmonizing its requirements with ISO 13485:2016, organizations must adapt their quality management systems to meet both FDA and international expectations.

A manufacturer planning a transition from the QSR to the QMSR must need to be aware of the laws, regulations, and standards involved in the change. From the FD&C Act and its supplementing regulations to the ISO medical device quality system requirements and definitions. What laws/regulations/standards does this involve?

Following are references to regulations and industry standards to help ensure a smooth and compliant transition.

FDA Regulations

• 21 CFR 820 – The Quality System Regulation (QSR)
• 21 CFR 820 (effective 2/2/26) – Quality Management System Regulation (QMSR)
• ISO 13485:2016 – Medical Devices – Quality management systems – Requirements for regulatory purposes
• ISO 9000:2015, Clause 3 – Quality management systems; Fundamentals and vocabulary
• The Food, Drug, & Cosmetic Act (FD&C)
• 21 CFR 4 – Regulation of Combination Products (updates will also be effective on 2/2/26)
• 21 CFR 803 – Medical Device Reporting
• 21 CFR 806 – Reports of Corrections and Removals
• 21 CFR 821 – Medical Device Tracking Requirements
• 21 CFR 830 – Unique Device Identification

Global ISO standards referenced by ISO 13485

• ISO 14644 – Cleanrooms and Associated Controlled Environments Package
• ISO 14698 – ISO Quality Management
• ISO 14971 – Medical devices – Application of risk management to medical devices
• IEC 62366–1 – Medical device Part 1: Application of usability engineering to medical devices
• ISO 11607-1 – Packaging for terminally sterilized medical devices. Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 11607-2 – Packaging for terminally sterilized medical devices. Part 2: Validation requirements for forming, sealing and assembly processes
• ISO 10012 – Measurement management systems — Requirements for measurement processes and measuring equipment
• ISO 19011 – Guidelines for auditing management systems