The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain.
The Result: Both the 21st Century Cures Act and recent FDA activities provide important, but incomplete, insight regarding regulation of health products utilizing artificial intelligence.
Looking Ahead: Digital health product manufacturers should recognize how recent regulatory changes may affect them, and that FDA is engaging industry to further refine its oversight approach.
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