FDA Issues a Final Rule Amending the Quality System Regulation (QSR)
The Food and Drug Administration (FDA) has issued a final rule amending the Quality System regulation (QSR). The title of the regulation has also been amended and will now be officially referred to as the Quality Management System Regulation (QMSR). The revision integrates ISO 13485:2016 requirements into the current framework of 21 CFR 820.
Final Rule Amending the Quality System Regulation (QSR)
The new rule modified the current good manufacturing practice (CGMP) requirements for devices within the Quality System (QS) Regulation under 21 CFR 820. This change aims to align more closely with the globally recognized ISO 13485:2016 standard as the FDA deems them significantly similar to the existing requirements providing an equivalent level of assurance in a firm’s quality management system and its ability to consistently produce safe, effective and high-quality medical devices.
FDA’s Revised Quality System Requirements for Medical Devices
The final rule establishes additional requirements within part 820 to clarify expectations and concepts used in ISO 13485. This ensures a seamless integration without creating inconsistencies with other applicable FDA requirements. Conforming edits have been made to part 4 (21 CFR part 4) to clarify Quality Management System (QMS) requirements for combination products. These edits do not impact the CGMP requirements for combination products.
The regulation takes effect two years after being published in the Federal Register. During this period, manufacturers must adhere to the QS regulation. The FDA will enforce the QMSR requirements starting from February 2, 2026.
References
- Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions
- Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP)
- Medical Devices; Quality System Regulation Amendments