Comment from AyurDatta Solutions LLC.
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Summary: AyurDatta Solutions, a physician-led clinical safety and governance firm, supports the pilot program and recommends that it explicitly require and measure documented human adjudication of AI-assisted safety outputs. They argue that while AI can detect and score signals, qualified human judgment is necessary for regulatory accountability and suggest using a "decision-boundary" audit trail as a vendor-neutral metric for trustworthiness.
AyurDatta Solutions submits the attached comment in response to Docket No. FDA-2026-N-4390. We recommend the pilot explicitly require, structure, and measure documented physician adjudication of AI-assisted safety outputs, and we propose a vendor-neutral, "decision-boundary" basis for evaluating the trustworthiness of proprietary AI systems. Our full response, organized by the Agency's question categories and numbers, is attached.