What this workspace makes usable.
FDA QMSRQuality Management System Regulation amendments to 21 CFR Part 820 is mapped here for regulated life-sciences, health-tech, AI governance, and operational quality work. US medical device quality-system rule that amends Part 820 and aligns the regulation more closely with ISO 13485:2016.
iFeed maps operational readiness for quality-system evidence. It does not replace legal, regulatory, or notified-body/FDA advice.
21 CFR Part 820 amendment
Regulatory text changes create a transition project, not only a policy update.
ISO 13485:2016 alignment
Quality-system language and evidence expectations move closer to international QMS structure.
Effective date 2026-02-02
Teams need implementation evidence before the rule is fully in effect.
Design and development controls
Design evidence must connect to risk, requirements, verification, validation, and change.
Risk management
Risk becomes part of the quality-system evidence fabric.
Supplier and purchasing controls
External-party quality evidence remains an operational weak point.
CAPA and complaint handling
Corrective action evidence must show decision logic and effectiveness.
Records and inspection readiness
The system must show current, controlled, retrievable records.
Primary references stay visible.
official firstFDA 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.
The workspace can grow without breaking the source trail.
stable structureThe ten subchapters are fixed surfaces for future public assets.
Overview · Source Library · Articles & Clauses · Applicability · Interpretation · Evidence Readiness · AI Governance · Operational Flow · Actors & Services · Updates & Assets