Top 10 Takeaways from FDA’s Revised Quality System Requirements for Medical Devices

Lexology February 9, 2024
Ropes & Gray LLP

On February 2, 2024, the U.S. Food and Drug Administration (“FDA”) published a final rule¹ to amend the current good manufacturing practice requirements for medical devices by harmonizing the existing requirements with ISO 13485:2016, the international consensus standard for device quality management systems used by regulatory authorities in many countries throughout the world. The revised requirements will be known as the Quality Management System Regulation (“QMSR”).

FDA’s final rule announcing the QMSR is generally consistent with the proposed rule issued in February 2022 (refer to our prior Ropes & Gray Alert). FDA determined that the requirements in ISO 13485:2016 are substantially similar to the requirements of FDA’s existing Quality System Regulation (“QSR”) in 21 C.F.R. Part 820 and provide a...

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