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CATEGORY: CLASSIFICATION

Substantial Equivalence

The regulatory standard for 510(k) clearance — a new device is substantially equivalent to a predicate if it has the same intended use and either identical or different but equally safe and effective technological characteristics.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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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RELATED TERMS

510(k) ClearancePredicate Device