US FDA finalises rule incorporating ISO 13485 into new Quality Management System Regulation (QMSR)

On February 2, 2024, the Food and Drug Administration (FDA) published a final rule to implement the most significant revisions in the FDA’s quality system requirements for medical devices in decades. Specifically, the final rule – known as the Quality Management System Regulation (QMSR) – will largely replace the FDA’s existing Quality System Regulation (QSR) with ISO 13485. The final rule also makes conforming edits to clarify the device Quality Management System requirements for combination products. This article by Pamela Forrest and Amy Leiser summarises the content of the QMSR, key differences between the QSR and QMSR, and steps that manufacturers should take to prepare for implementation of the QMSR.