CATEGORY: REGULATORY PATHWAYS

De Novo Classification

An FDA pathway for novel, low-to-moderate risk devices that lack a predicate. De Novo creates a new classification regulation, which can then serve as a predicate for future 510(k) submissions.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

WHEN IT APPLIES

De Novo is for novel low-to-moderate risk devices without a predicate. A successful De Novo creates a new classification that future devices may cite as a 510(k) predicate.

PROCESS / STEPS

Confirm no suitable predicate exists.
Prepare benefit-risk and special controls rationale.
Submit De Novo request with performance and clinical data as needed.
After grant, maintain postmarket controls and labeling.

EXAMPLES

First-of-a-kind digital diagnostics without a clear predicate often evaluate De Novo.

RELATED GUIDES & TOOLS

SOURCES

FDA De Novo Classification ↗

Track regulatory signals related to De Novo Classification across 27 authorities in real time.

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