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类别: REGULATORY PATHWAYS
上市前通知
510(k)提交的正式名称——向FDA发出的制造商拟上市器械的上市前通知。FDA在接受510(k)后有90天的回应时间。
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
Premarket notification is the statutory name for the US 510(k) process—notifying FDA of intent to market a device and demonstrating substantial equivalence to a predicate.
PROCESS / STEPS
- Confirm 510(k) is the correct path.
- Build SE evidence package.
- Submit and manage FDA interactive review.
- Market only after clearance letter.
EXAMPLES
- “Premarket notification” and “510(k)” are often used interchangeably in industry language.
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SOURCES
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