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FDA's Generative AI Discussion Paper Signals a Break from the Past in Terminology, But ...
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Fusion42 · 2 September 2026 · Fusion42 review
The FDA's discussion paper on generative AI-enabled medical devices signals potential shifts in terminology and regulatory approach, focusing on a competency-based evaluation model and revisiting risk assessment frameworks while inviting stakeholder feedback by October 19, 2026.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
You must prepare for a major rewrite in FDA compliance if you build generative AI medical devices. Engage deeply with the FDA’s questions by October 19 to shape a regulator process that could rapidly change market access and product design.
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1 source · 2 Sep 2026
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