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CATÉGORIE: CLASSIFICATION

Dérive de prédicat

Le phénomène où des clearances 510(k) successives s'éloignent significativement du prédicat original.

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

Predicate creep describes incremental technological changes across successive 510(k) clearances that, over generations, drift far from the original predicate’s technology—raising substantial equivalence and safety questions.

PROCESS / STEPS

  1. Map multi-generation predicate chains when selecting predicates.
  2. Assess whether cumulative differences require De Novo or PMA instead of forced SE.
  3. Document technological characteristics honestly; do not hide stepwise drift.
  4. Consider clinical data when differences could affect safety/effectiveness.

EXAMPLES

  • A long chain of “me-too” imaging accessories may no longer resemble the original predicate’s risk profile.

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TERMES CONNEXES

Clearance 510(k)Dispositif prédicatÉquivalence substantielleClassification De Novo