The US FDA released its final rule on QMS, furthering global harmonization of regulatory requirements.
The U.S. Food and Drug Administration (FDA) released on Friday, 2 February 2024 its final ruling on amending the Quality Management System Regulation (QMSR). The amendment incorporates a reference to ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. This furthers the global harmonization of quality management system regulatory requirements for medical devices.
Additional details can be found at Quality System Regulation and Medical Device GMPs.