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類別: CLASSIFICATION
等同漂移
連續510(k)許可使用的等同器材本身也是基於更早等同器材獲得許可的現象，可能導致當前上市器材與原始等同器材存在顯著差異。
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
- 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.
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