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📋 AI Medical Device Approval Pathway Navigator Simulator

This simulation helps users navigate the approval pathway for AI medical devices in FDA or EMA, depending on the device type, by providing detailed information about the regulatory requirements and processes involved.

AI/ML SaMD Regulatory Pathway2DModerate60 FPS

Classifying an AI/ML Device Before Any Pathway Is Chosen

Placeholder lead — risk class drives everything downstream.

I / II / III: Device classes (placeholder caption)
~97%: Class II share of AI/ML clearances (placeholder caption)
Risk to patient: Determinant (placeholder caption)
FDA CDRH: Regulator (placeholder caption)

How risk class gets assigned

Placeholder body text — short stand-in for full explanation.

Does a Substantially Equivalent Predicate Device Exist?

Placeholder lead — predicate availability forks the pathway.

510(k) archive: Predicate database (placeholder caption)
Same intended use: Equivalence test (placeholder caption)
De Novo eligible: No predicate outcome (placeholder caption)
PMA required: High risk override (placeholder caption)

Why the predicate question matters

Placeholder body text — short stand-in for full explanation.

Three Pathways, Three Very Different Review Postures

Placeholder lead — 510(k), De Novo, and PMA diverge sharply.

Substantial equivalence: 510(k) basis (placeholder caption)
Novel, moderate risk: De Novo basis (placeholder caption)
Clinical trial evidence: PMA basis (placeholder caption)
510(k): Fastest pathway (placeholder caption)

What routes a device to each track

Placeholder body text — short stand-in for full explanation.

Review Timelines and Evidence Burden by Pathway

Placeholder lead — each track runs its own clock and dossier.

~3–6 months: 510(k) review (placeholder caption)
~8–12 months: De Novo review (placeholder caption)
~18–30 months: PMA review (placeholder caption)
Clinical trial data: PMA evidence (placeholder caption)

Evidence stacks grow with risk

Placeholder body text — short stand-in for full explanation.

Time-to-Market vs. Evidence Burden — the Core Tradeoff

Placeholder lead — faster pathways demand less proof, not more.

Low: 510(k) burden (placeholder caption)
Moderate: De Novo burden (placeholder caption)
High: PMA burden (placeholder caption)
New predicate created: De Novo precedent (placeholder caption)

Why pathway choice is strategic

Placeholder body text — short stand-in for full explanation.

Placeholder highlight — De Novo clearance becomes a future predicate.

⚙ Under the hood

This simulation helps users navigate the approval pathway for AI medical devices in FDA or EMA, depending on the device type, by providing detailed information about the regulatory requirements and processes involved.

CanvasBiomedicine

2D · HTML5 Canvas 2D · 60 FPS target · runs fully client-side, no install