On 2 February 2024 FDA published the final Quality Management System Regulation (QMSR), amending 21 CFR Part 820 to incorporate ISO 13485:2016 by reference. The effective date was set two years out, 2 February 2026, to give manufacturers time to adjust.
What the rule does
It replaces most of the existing QS regulation text with a reference to ISO 13485:2016, adds definitions and clarifications where FDA terminology differs, and retains FDA-specific requirements on records, labelling, and complaint handling in support of Medical Device Reporting. FDA also announced it would replace the QSIT inspection approach.
What manufacturers should do in 2024
- Map the QMSR text against the current quality manual and identify differences in definitions and scope.
- If not already certified to ISO 13485:2016, decide whether certification is worthwhile (it is not required, but it aligns evidence).
- Plan internal audits against the QMSR for 2025 so there is at least one cycle before the effective date.
Vakula's quality consultants run QMSR gap assessments and support the remediation. See GxP audit and quality.