Source library for FDA QMSR.
verified anchorsFDA Quality Management System Regulation page
Current · FDA source page for QMSR background and implementation information.
Federal Register final rule
2024-02-02 · Final rule amending device quality-system requirements; effective date 2026-02-02.
21 CFR Part 820
Current · Current codified regulation text for Part 820 source checks.
What can be used publicly and what must stay bounded.
public-safeOfficial source first
Use regulator, source-owner, EUR-Lex, FDA, EMA, ICH, ISO/IEC, ISPE, IMDRF, Health Canada, MHRA or similar authority/source-owner pages before commentary.
Paid-source boundary
Where a standard or guide is protected, the page names the source and describes public-safe implications without reproducing protected clause text.
Status visible
Every source needs date/status language so draft, final, watch item, and effective/applicable dates are not mixed.
Interpretation separated
Source fact and iFeed interpretation must remain visibly separated before any checklist is published.
Objects that deserve stable child pages.
future expansion21 CFR Part 820 scope and definitions
Use eCFR as the current codified rule text for FDA device QMS requirements.
QMSR final rule preamble
Use Federal Register context for FDA rationale, transition, and response to comments.
ISO 13485:2016 incorporation boundary
Reference only; do not reproduce protected ISO clause text.
FDA-specific provisions
Keep FDA-specific statutory, inspection, enforcement, labeling, packaging, and record expectations visible.
21 CFR Part 4 bridge
Combination-product teams need to understand device-constituent implications.
Inspection transition
Effective-date readiness is an operational file, not only an SOP update.