Design Controls Were Built for Outputs, Not Agentic Reasoning
FDA's total product life cycle framework for AI-enabled devices documents data lineage and output correctness, but not the intermediate process failures unique to agentic architectures.
The Real Gap Isn't Evidence. It's Framework Fit.
AI medical device clearances are outpacing the regulatory architecture meant to govern them, and hospitals are deploying generative AI ahead of any classification at all.
