From February 2, 2026, the new Quality Management System Regulation (QMSR) takes effect in the USA and replaces the previous FDA Quality System Regulation (21 CFR Part 820).
With the QMSR, the FDA adopts ISO 13485:2016 “by reference” as the central framework for the quality management systems of medical device manufacturers.
ISO 13485 is therefore now the de facto standard in the USA as well.
The QMSR is available here: Federal Register :: Medical Devices; Quality System Regulation Amendments; Correction