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類別: REGULATORY PATHWAYS
突破性器材認定
FDA為提供更有效治療或診斷危及生命或不可逆衰弱疾病的器材提供優先審查的計畫。提供互動審查、優先審查和高級管理層參與。
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
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