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CATEGORY: REGULATORY PATHWAYS
Breakthrough Device Designation
An FDA program providing prioritized review for devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. Provides interactive review, priority review, and senior management involvement.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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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