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类别: REGULATORY PATHWAYS
De Novo分类
一种FDA途径，适用于缺乏等同器械的新型低至中等风险器械。De Novo创建新的分类规定，可作为未来510(k)提交的等同依据。
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
De Novo is for novel low-to-moderate risk devices without a predicate. A successful De Novo creates a new classification that future devices may cite as a 510(k) predicate.
PROCESS / STEPS
- Confirm no suitable predicate exists.
- Prepare benefit-risk and special controls rationale.
- Submit De Novo request with performance and clinical data as needed.
- After grant, maintain postmarket controls and labeling.
EXAMPLES
- First-of-a-kind digital diagnostics without a clear predicate often evaluate De Novo.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to De Novo分类 across 27 authorities in real time.
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