ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA publishes a major regulation to converge US quality system rules with the global ISO 13485 standard, and it hires a new device cybersecurity director from industry as part of a reorganization. In the EU, a final draft of the AI Act is circulating and policymakers issued medical device vigilance reporting templates. Also: e-labeling comments, Philips agrees to a consent decree, new UK Approved Bodies, and more.
Top Pick: Quality Overhaul
FDA issues QMSR rule to align with global standards, allowing two years for transition:
FDA published its hotly anticipated Quality Management System Regulation rule January 31, cementing plans to converge US quality management rules more fully with global practices. Specifically, FDA will replace the long-standing Quality System Regulation with an “incorporation by reference” to the global ISO 13485:2016 QMS standard, with addendums and edits to ensure the new rule complies with US law.
Although the industry largely supports the move toward more alignment in outlying US requirements with the rest of the world, companies said the 2022 proposed QMSR rule would add up to significant transition burdens. (See “QSR is Dead, Long Live QMSR? 5 Topics to Watch in FDA’s Proposed Quality Framework,” Market Pathways, February 22, 2022.) In response, FDA agreed to a request from companies to extend the proposed one-year transition time to two years (although some asked for even longer). The QMSR requirements will take effect February 2, 2026. Otherwise, FDA’s final rule stuck closely to its 2022 proposal. The agency suggested that it avoid tweaking too many terms and definitions or more precisely mapping sections from the legacy QSR to the new QMSR to avoid unnecessary duplication and complications. A few other notable takeaways from the final QMSR rule:
