The transition period for FDA’s Quality Management System Regulation (QMSR), which replaces 21 CFR Part 820, will end on February 2, 2026, aligning the medical device quality system requirements with the international standard ISO 13485:2016. This change will simplify compliance for manufacturers and reduce the burden of adhering to two sets of regulations.
The QMSR largely replaces the requirements of 21 CFR Part 820 by directly incorporating ISO 13485:2016 by reference. This means that medical device manufacturers will primarily follow ISO 13485:2016 for their quality management systems, while additional requirements are retained or clarified by the FDA.
- Risk Management: The QMSR, through its adoption of ISO 13485:2016, places more emphasis on risk management throughout the entire product lifecycle, from design to post-market activities.
- Terminology: The QMSR adopts many of the definitions and terminology used in ISO 13485:2016, e.g., by replacing the term “Device Master Record” (DMR) with “Medical Device File”.
- Retention of Specific FDA Requirements: While incorporating ISO 13485, the FDA has retained certain specific requirements to ensure consistency with other applicable FDA regulations, including those for reporting (21 CFR 803), advisory notices (21 CFR 806), traceability (21 CFR 821), and UDI requirements (21 CFR 830).
- Management Review and Audits: Management review, quality audits, and supplier audit reports will be subject to review during establishment inspections, aligning with ISO 13485:2016 practices.
Most companies operating internationally or participating in the Medical Device Single Audit Program (MDSAP) have already established compliance with ISO13485. However, some minor adjustments may be necessary as part of the transition to the QMSR. References to 21 CFR 820 should be removed after the transition period ends, and terminology should align with that used in ISO 13485. Nonetheless, specific requirements from 21 CFR 800 ff. continue to apply, and should be addressed in the quality management system. Procedures may need to be updated to reflect that the Quality System Inspection Technique (QSIT) will be phased out and that the FDA will review management review records and audit records.
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