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AI radiology tools are closest to full autonomy, but the FDA's regulatory framework still assumes human-in-the-loop oversight.
True if FDA grants approval for an AI system to make diagnostic decisions without mandatory physician review.
426 days remaining provides runway
1,357+ AI-enabled devices already authorized demonstrates regulatory pathway normalizing
105-day clearance timeline confirms FDA actively processing AI medical tool submissions
Anthropic red team disclosure of exploit-capable autonomous AI models may intensify FDA caution about autonomous AI systems in safety-critical medical contexts
No De Novo or 510(k) submission for fully autonomous diagnostic tool documented in any cycle
FDA's preferred architecture consistently remains AI-as-support with physician review — no signal of framework change
AMA lobbying against physician oversight removal structurally unchanged
8-state lawsuits against OpenAI for misleading safety claims may increase FDA's scrutiny requirements for AI medical claims