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CATÉGORIE: REGULATORY PATHWAYS

Classification De Novo

Une voie FDA pour les dispositifs innovants à risque faible à modéré sans prédicat. De Novo crée une nouvelle réglementation de classification.

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

Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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

  1. Confirm no suitable predicate exists.
  2. Prepare benefit-risk and special controls rationale.
  3. Submit De Novo request with performance and clinical data as needed.
  4. 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

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TERMES CONNEXES

Clearance 510(k)Dispositif prédicatRègle de classification