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類別: REGULATORY PATHWAYS
特殊510(k)
針對器材修改的簡化510(k)途徑，製造商可依靠設計控制文件證明變更不影響安全性或有效性。審查30天，而傳統510(k)為90天。
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
A Special 510(k) is an FDA pathway for certain device modifications by the same manufacturer relying on design control documentation rather than a full Traditional 510(k), when criteria are met.
PROCESS / STEPS
- Confirm eligibility vs Traditional/Abbreviated 510(k).
- Document design controls and risk analysis for the change.
- Submit Special 510(k) package with clear change description.
- Update labeling/production after clearance.
EXAMPLES
- A well-controlled material supplier change may qualify when performance is unchanged and design controls are robust.
RELATED GUIDES & TOOLS
SOURCES
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