US FDA News!! (FDA – Quality Management System Regulation)
The FDA has published (31-Jan) the “Quality Management System Regulation final rule”
This rule amends 21 CFR 820 by incorporating by reference the quality management system requirements of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016. The rule renames the regulation to the Quality Management System Regulation (QMSR).
The rule is effective two years after publication in the Federal Register. Until then manufacturers are required to comply with the QS regulation. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.
FDA will develop a new inspection process to align with the requirements of the new Quality Management System Regulation (QMSR). The process will be developed for implementation when the rule takes effect.
Know more about our Quality Management System (QMS) regulatory services at https://lnkd.in/dt4tQYNy