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KATEGORIE: CLASSIFICATION
Wesentliche Gleichwertigkeit
Der regulatorische Standard für die 510(k)-Zulassung — ein neues Gerät ist wesentlich gleichwertig, wenn es die gleiche Zweckbestimmung und gleiche oder gleichwertige technologische Merkmale hat.
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
- Map intended use and indications carefully against the predicate.
- List technological differences and evaluate new questions of safety/effectiveness.
- Provide performance data to bridge differences.
- Address labeling parity and residual risk.
EXAMPLES
- A material change with biocompatibility and performance data may still support SE.
RELATED GUIDES & TOOLS
SOURCES
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