Overview — 21 CFR Part 820 & the QMSR
The QMSR (and its predecessor, the QSR) is a US-specific regulatory requirement. While aligned with ISO 13485:2016, it is a US federal regulation with distinct enforcement mechanisms — FDA inspections, warning letters, and consent decrees.
From QSR to QMSR
FDA's quality system requirements for device manufacturers have been in place since 1978. The most recent significant update:
- Original QSR (21 CFR Part 820) — effective 1996, required US device manufacturers to implement a quality system covering design controls, production, and post-market activities
- QMSR final rule — published in February 2024, effective February 2, 2026
The QMSR amends 21 CFR Part 820 to align with ISO 13485:2016 — meaning manufacturers with a conforming ISO 13485 QMS will largely satisfy QMSR requirements, though additional US-specific requirements still apply.
Key change: QMSR = ISO 13485 + US-specific additions
The QMSR incorporates ISO 13485:2016 by reference but adds several US-specific requirements:
- Complaint handling integrated with MDR (Part 803)
- Design history file (DHF) terminology maintained
- CAPA aligned with FDA enforcement expectations
- Correction and removal provisions (Part 806)
Who must comply with QMSR?
All manufacturers of finished devices distributed in the USA must comply with QMSR. This includes:
- US manufacturers
- Foreign manufacturers exporting to the USA
- Repackagers and relabellers (treated as manufacturers)
Exemptions: Class I devices that are also exempt from 510(k), with some exceptions (CAPA, complaint handling, and MDR procedures still apply to Class I manufacturers).