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類別: REGULATORY PATHWAYS
簡化510(k)
依靠FDA認可的標準、指南文件或特殊控制來證明實質等效的510(k)提交。如果器材符合認可的共識標準，可能需要較少的臨床數據。
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
An Abbreviated 510(k) relies on guidance documents, special controls, and/or voluntary consensus standards to streamline demonstration of substantial equivalence.
PROCESS / STEPS
- Identify applicable FDA guidance and recognized standards.
- Provide summary reports and declarations of conformity.
- Address any residual differences vs predicate.
- Submit and respond to FDA questions.
EXAMPLES
- Devices with well-established product codes and standards often benefit from abbreviated documentation strategies.
RELATED GUIDES & TOOLS
SOURCES
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