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类别: CLASSIFICATION
等同漂移
连续510(k)许可使用的等同器械本身也是基于更早等同器械获得许可的现象，可能导致当前上市器械与原始等同器械存在显著差异。批评者认为这削弱了安全保证。
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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