Update: January 31, 2024
The FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. This final rule is the latest action taken by the FDA to promote consistency in the regulation of devices. This action will harmonize the FDA’s CGMP regulatory framework with that used by other regulatory authorities.
The rule is effective February 2, 2026, two years after publication. Until then, manufacturers are required to comply with the QS regulation.