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类别: REGULATORY PATHWAYS
突破性器械认定
FDA为提供更有效治疗或诊断危及生命或不可逆衰弱疾病的器械提供优先审查的计划。提供互动审查、优先审查和高级管理层参与。
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 突破性器械认定 across 27 authorities in real time.
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