FDA SaMD / AI Device Clearance
Regulatory approval for clinical AI
The FDA's Software-as-a-Medical-Device pathway governs AI used in diagnosis and treatment, with 1,000+ authorizations by 2025 and an evolving framework for adaptive/generative models. Clearance timelines and the challenge of regulating self-updating models are a structural brake on clinical AI.
Authorizations
1,000+ AI/ML devices
Open problem
Regulating adaptive models
How it fits the stack
FDA SaMD / AI Device Clearance with what it depends on (above) and what it feeds (below). The figure renders as a crawlable diagram and upgrades to an interactive 3D graph as it scrolls into view.
FDA SaMD / AI Device Clearance in the AI stack. FDA SaMD / AI Device Clearance with its immediate upstream dependencies (top) and downstream dependents (bottom) in the AI value chain. Hover a node in 3D, or read the full relationships below.
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Context — capital, rivals, policy · · 1