On 2 February 2024, the US Food and Drug Administration (FDA) published its much anticipated final rule amending the medical device Quality System Regulation, which sets out the FDA’s quality management system (QMS) requirements for medical devices. The amendments seek to align more closely with International Standard Organization (ISO) standard 13485:2016, Medical Devices — Quality Management System Requirements for Regulatory Purposes. The ISO standard is the version used in much of the world and provides a good framework for meeting the requirements in the EU Medical Devices Regulation (MDR).
The FDA’s decision to align the US QMS requirements to international standards is one of many efforts undertaken by the Agency to promote global regulatory harmonization. Ex-US device and tech developers will hopefully receive some of the efficiency and alignment they were hoping for when it comes to quality system compliance requirements in the US.
You can read more in our advisory.