Manufacturers of medical devices intending to market their products in the United States are currently required to comply with the U.S. FDA’s 21 CFR Part 820: Quality System Regulation (QSR). Non-compliance with any applicable provision of the QSR renders a device adulterated under Section 501(h) of the Food, Drug, and Cosmetic Act, and may result in regulatory action against both the product and the responsible individuals.
On February 2, 2024, the FDA issued a final rule that replaces the QSR with a new regulation—the Quality Management System Regulation (QMSR)—which harmonises U.S. requirements with ISO 13485:2016. The QMSR will officially come into effect on February 2, 2026. Organisations already certified or aligned with ISO 13485:2016 are expected to experience minimal disruption. However, manufacturers currently operating solely under 21 CFR Part 820 and not aligned with ISO 13485 will be more significantly impacted.
This course provides a detailed overview of the QMSR structure and highlights the key updates and additional requirements beyond ISO 13485:2016. A working knowledge of ISO 13485:2016 is assumed. If further knowledge on the ISO 13485:2016 is required please see more details on ISO 13485:2016 training programme.
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