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AHA Recommends FDA Permanently Adopt CDS Flexibilities, Clarify 'General Wellness' Policy
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Fusion42 · 15 August 2026 · Fusion42 review
The American Hospital Association recommends the FDA permanently maintain some Clinical Decision Support (CDS) flexibilities, clarify its 'general wellness' policy for low-risk devices, and update guidance to address new AI applications including generative AI.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
You must anticipate ongoing FDA flexibility on clinical decision software and seek clarity on device classifications as AI uses grow. This opens the door to faster US market entry if you adapt your medtech products to evolving rules now.
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1 source · 15 Aug 2026
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