The FDA recently issued the Final Rule for the Quality Management System Regulation (QMSR) that amends the current medical device cGMP requirements of the Quality System (QS) regulation (21 CFR 820).
The FDA over the last few years has been looking to harmonize its medical device CGMP regulatory compliance and this action continues its efforts to align with other regulatory authorities to promote consistency in the regulation of devices and provide a timelier introduction of safe, effective, high-quality devices for patients.
Effective February 2, 2026, two years after the publication of the final rule, FDA will begin to enforce the QMSR requirements upon the effective date. Until then, manufacturers are required to comply with the QS regulation.
What is Changing?
Title: The new rule amends the title of the regulation. The revised part 820 will be referred to as the Quality Management System Regulation (QMSR).
Requirements: 21 CFR 820 has been amended by incorporating the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. The FDA implemented this final ruling to promote consistency in the regulation of medical devices.
Additionally, the rule establishes more requirements that clarify certain expectations and certain concepts used in ISO 13485 to mitigate inconsistencies with other applicable FDA requirements. FDA has also made conforming edits to part 4 (21 CFR part 4) to clarify the device Quality Management System (QMS) requirements for combination products. These edits do not impact the CGMP requirements for combination products.