How many controls does FDA Quality Management System Regulation have?

FDA Quality Management System Regulation contains 34 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 264 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.

FDA Quality Management System Regulation (QMSR)

The FDA Quality Management System Regulation (QMSR), effective February 2026, replaces the Quality System Regulation (21 CFR Part 820) by incorporating ISO 13485:2016 by reference. It aligns FDA quality system requirements for medical device manufacturers with the international standard, reducing regulatory burden for manufacturers operating globally while maintaining FDA-specific requirements for design controls and post-market surveillance..

Domains

Regulatory Compliance and Traceability

Measurement, Analysis, and Improvement

Production and Process Controls

Design and Development

Resource Management

Frequently Asked Questions

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