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Breakthrough Device Designation
Ein FDA-Programm mit priorisierter Prüfung für Geräte, die eine wirksamere Behandlung oder Diagnose lebensbedrohlicher Erkrankungen bieten.
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
- Assess eligibility against FDA breakthrough criteria.
- Request designation with preliminary data package.
- Use interactive review features during premarket submission.
- Maintain postmarket commitments if applicable.
EXAMPLES
- Novel diagnostics addressing serious unmet needs often pursue breakthrough designation.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Breakthrough Device Designation across 27 authorities in real time.
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