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CATÉGORIE: REGULATORY PATHWAYS

Notification pré-commercialisation

Le nom formel d'une soumission 510(k) — une notification pré-commercialisation à la FDA.

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

Premarket notification is the statutory name for the US 510(k) process—notifying FDA of intent to market a device and demonstrating substantial equivalence to a predicate.

PROCESS / STEPS

  1. Confirm 510(k) is the correct path.
  2. Build SE evidence package.
  3. Submit and manage FDA interactive review.
  4. Market only after clearance letter.

EXAMPLES

  • “Premarket notification” and “510(k)” are often used interchangeably in industry language.

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SOURCES

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TERMES CONNEXES

Clearance 510(k)Équivalence substantielleDispositif prédicat