ARTICLE SUMMARY:
In this week’s roundup: FDA’s long-awaited proposed rule to harmonize its Quality System Regulation with the ISO 13485 global standard is imminent; the device center, and the Hill, lays out equity goals underscored by digital health; CMS schedules listening sessions on medtech Medicare coverage; Cancer Moonshot; False Claims healthcare haul; China technical requirements guide, and more.
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What we’re watching for:
QSR revamp. FDA’s long-in the-works proposal to align its Quality System Regulation with the global ISO 13485 standard could be out any day. The final review step by the White House Office of Information and Regulatory Affairs appears complete. QSR underlies companies’ approach to device design, manufacturing, and validation in the US and for FDA’s facility inspections. But 13485 guides practices in most of the rest of the world. The extent to which FDA’s proposed rule harmonizes the two frameworks could significantly reduce duplication and cost from manufacturers’ global compliance strategies, but the devil will be in the details. The agency is not expected to adopt the ISO standard without some variation and the transition/implementation process could be complicated. Once the proposed rule is out, “companies should really be thinking about, ‘what do I need to do to make that transition,’ and not really wait for a final rule,” CDRH Director Jeff Shuren stressed during a recent webinar sponsored by MassMEDIC. “The ISO standard is the ISO standard.”
