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CATEGORY: CLASSIFICATION
Predicate Creep
The phenomenon where successive 510(k) clearances use predicates that are themselves cleared based on earlier predicates, potentially resulting in currently marketed devices that differ significantly from the original predicate. Critics argue this weakens safety assurance.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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
- Map multi-generation predicate chains when selecting predicates.
- Assess whether cumulative differences require De Novo or PMA instead of forced SE.
- Document technological characteristics honestly; do not hide stepwise drift.
- 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.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Predicate Creep across 27 authorities in real time.
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