QMSR Is Coming: Why FDA Inspections Will Change Completely in 2026

Medical Device made Easy Podcast · Jan 28, 2026

For decades, medical device manufacturers in the US relied on 21 CFR 820 (QSR) — a system known for being procedural and checklist-oriented.

But starting February 2nd, 2026, FDA will implement QMSR, changing not only the regulation structure but also the inspection philosophy.

QMSR does not eliminate Part 820. Instead, FDA is amending it to incorporate ISO 13485:2016 by reference, bringing the US closer to the global quality language used across Europe, Canada, Japan, and beyond.

Why FDA is doing this

FDA’s move is driven by three key goals:

Harmonization (reduce duplicated systems and…