Pathways' Pick of the Week: Quality Overhaul

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ARTICLE SUMMARY:

FDA has issued its QMSR rule to align with global standards, allowing two years for transition. Excerpted from Pathways’ Picks January 31: FDA Globalizes Quality Rules, Hires Cyber Director, Europe’s AI Act Circulates, and More.

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:

  • FDA says it expects QMSR compliance to “largely satisfy” the ISO 13485 standard (used in Europe and elsewhere), but affirmed that an ISO 13485 certification will not serve as a substitute for an FDA inspection.
  • The agency says it will review its current guidances and procedures, update staff training, and update its documentation with regards to participation in the Medical Device Single Audit Program (MDSAP) to align with QMSR, but that it doesn’t anticipation major revisions. “Because we consider the [Quality System] regulation and the QMSR to be substantially similar, we expect to update guidance documents for consistency but do not expect there to be many differences in interpretation of these regulations or application of relevant policies.”
  • FDA acknowledged there is only so much it can do to support companies’ transition to the QMSR: “Because each organization’s QMS is unique to its operations, FDA is not able to provide advice about how each organization should evaluate its existing QMS for consistency with the QMSR.”
  • One key update FDA did make in the final rule compared to the proposal: It agreed to incorporate a segment of the more general QMS standard, ISO 9000:2015, into its new regulations, because it “contains terms and definitions that are indispensable for the application of ISO 13485.”
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