Quality ManagementUnited States
FDA Quality Management System Regulation (QMSR)
The new 21 CFR Part 820 (Quality Management System Regulation, QMSR) was published as a Final Rule on 31 January 2024 (89 FR 7496) and applies from 2 FEBRUARY 2026. It HARMONISES the FDA medical device quality system requirements with ISO 13485:2016 by INCORPORATING THAT STANDARD BY REFERENCE under §820.7 + retaining a small number of FDA-specific additions (§820.15 clarifications + §820.35 record controls including audit trail + UDI + reporting + §820.45 device labelling + packaging controls).
Domains
QMSR: Scope, Definitions, Incorporation by Reference (§§820.1-820.7)
QMSR: Device Labelling and Packaging Controls (§820.45)
QMSR: Clarification of Concepts and Definitions (§820.15)
QMSR: Transition Plan from Prior QSR, FDA Inspection Approach, Status
QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8)
Compare FDA Quality Management System Regulation (QMSR)
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FDA Quality Management System Regulation (QMSR) by Industry
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FDA Quality Management System Regulation (QMSR) by Role
FDA Quality Management System Regulation (QMSR) for CISOs→FDA Quality Management System Regulation (QMSR) for Compliance Officers→FDA Quality Management System Regulation (QMSR) for Risk Managers→FDA Quality Management System Regulation (QMSR) for IT Directors→FDA Quality Management System Regulation (QMSR) for DPOs→FDA Quality Management System Regulation (QMSR) for Auditors→
Frequently Asked Questions
What is FDA Quality Management System Regulation?
The new 21 CFR Part 820 (Quality Management System Regulation, QMSR) was published as a Final Rule on 31 January 2024 (89 FR 7496) and applies from 2 FEBRUARY 2026. It HARMONISES the FDA medical device quality system requirements with ISO 13485:2016 by INCORPORATING THAT STANDARD BY REFERENCE under §820.7 + retaining a small number of FDA-specific additions (§820.15 clarifications + §820.35 record controls including audit trail + UDI + reporting + §820.45 device labelling + packaging controls).
How many controls does FDA Quality Management System Regulation have?
FDA Quality Management System Regulation contains 13 controls organized across 7 domains.
Where does FDA Quality Management System Regulation apply?
FDA Quality Management System Regulation is applicable in United States. Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.
What frameworks does FDA Quality Management System Regulation map to?
FDA Quality Management System Regulation has control-to-control mappings with 153 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.
How do I get started with FDA Quality Management System Regulation compliance?
Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.
How ready are you for FDA Quality Management System Regulation (QMSR)?
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