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