The 101-page Federal Register (FR) document published on the prepublication page of the FR today (here) describes the rule in detail and provides responses to comments received by stakeholders on the proposed final rule.
The FDA states:
“We are amending part 820, primarily to incorporate by reference ISO 13485, Medical Devices—Quality Management System Requirements for Regulatory Purposes. While the QS regulation provided sufficient and effective requirements for the establishment and maintenance of a QMS, regulatory expectations for a QMS have evolved since the QS regulation was implemented over 20 years ago. By incorporating ISO 13485 by reference, we are explicitly requiring current internationally recognized regulatory expectations for QMS for devices subject to FDA’s jurisdiction. This resulting regulation is referred to as the QMSR.”
The rule provides a history of the Agency’s actions leading up to this final rule and identifies its goal of harmonizing the QMSR with the rest of the world through reference to the ISO standards. The FR notice indicates that the final rule has an effective date of February 2, 2026.
In the rule, the FDA says that it is providing additional definitions and, in a few instances, providing clarifications of some “concepts or augmenting specific clauses in ISO 13485 but overall, we [FDA] are not modifying the clauses in ISO 13485.” The FDA also notes that, while the final rule is amending parts of 21 CFR 820, it does not change the Agency’s inspectional authority.
It is a lot to slug through but, for those of you who are involved with medical device compliance and requirements, it is a must-read. Enjoy! The final rule will be published officially on February 2, 2024 in the FR.
