The new final rule on the Quality Management System Regulation (QMSR) amends the current good manufacturing practice (cGMP) requirements for medical devices under 21 CFR Part 820.

This revision underscores the FDA’s commitment to harmonizing domestic regulatory requirements with internationally recognized standards, with the aim of enhancing device quality, reducing compliance burdens for manufacturers operating in multiple markets, and facilitating global trade.

Among the key changes is the incorporation of ISO 13485:2016 terminology and definitions to ensure consistency while maintaining specific FDA requirements and ongoing regulatory oversight.

The new QMSR seeks to streamline regulatory expectations, increase industry efficiency, and ensure high standards of safety and effectiveness for medical devices.