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实质等效

510(k)许可的法规标准——如果新器械与等同器械具有相同的预期用途，以及相同或不同但同样安全有效的技术特征，则实质等效。

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

Substantial equivalence (SE) is the FDA legal standard for most 510(k) clearances: same intended use and technological characteristics that are as safe and effective as the predicate.

PROCESS / STEPS

  1. Map intended use and indications carefully against the predicate.
  2. List technological differences and evaluate new questions of safety/effectiveness.
  3. Provide performance data to bridge differences.
  4. Address labeling parity and residual risk.

EXAMPLES

  • A material change with biocompatibility and performance data may still support SE.

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SOURCES

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相关术语

510(k)许可等同器械