AI/ML Device Approval

FDA pathway routing for AI/ML-based medical devices — 510(k) substantial equivalence, De Novo classification, and PMA clinical review

Current Stage

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Risk Class

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Pathway

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Review Timeline

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Evidence Burden

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Device Risk LevelModerate

Predicate AvailabilityExists

510(k) — substantial equivalence

De Novo — novel, moderate risk

PMA — highest risk, clinical data

Evidence requirement unit

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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

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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

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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

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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

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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

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Placeholder highlight — De Novo clearance becomes a future predicate.