QMSR
The FDA's 21 CFR Part 820 as amended to incorporate ISO 13485:2016 by reference, replacing the earlier Quality System Regulation (QSR). It took effect on February 2, 2026.
The FDA's 21 CFR Part 820 as amended to incorporate ISO 13485:2016 by reference, replacing the earlier Quality System Regulation (QSR). It took effect on February 2, 2026.