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CATÉGORIE: REGULATORY PATHWAYS

Désignation Breakthrough Device

Un programme FDA offrant un examen prioritaire pour les dispositifs offrant un traitement ou diagnostic plus efficace de conditions potentiellement mortelles.

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

FDA Breakthrough Device Designation prioritizes devices for more effective treatment/diagnosis of life-threatening or irreversibly debilitating conditions.

PROCESS / STEPS

  1. Assess eligibility against FDA breakthrough criteria.
  2. Request designation with preliminary data package.
  3. Use interactive review features during premarket submission.
  4. Maintain postmarket commitments if applicable.

EXAMPLES

  • Novel diagnostics addressing serious unmet needs often pursue breakthrough designation.

RELATED GUIDES & TOOLS

SOURCES

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TERMES CONNEXES

Clearance 510(k)Approbation pré-commercialisation (PMA)Classification De Novo