← Tous les termes
CATÉGORIE: REGULATORY PATHWAYS

510(k) spécial

Une voie 510(k) simplifiée pour les modifications de dispositifs, examinée en 30 jours au lieu de 90.

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

A Special 510(k) is an FDA pathway for certain device modifications by the same manufacturer relying on design control documentation rather than a full Traditional 510(k), when criteria are met.

PROCESS / STEPS

  1. Confirm eligibility vs Traditional/Abbreviated 510(k).
  2. Document design controls and risk analysis for the change.
  3. Submit Special 510(k) package with clear change description.
  4. Update labeling/production after clearance.

EXAMPLES

  • A well-controlled material supplier change may qualify when performance is unchanged and design controls are robust.

RELATED GUIDES & TOOLS

SOURCES

Track regulatory signals related to 510(k) spécial across 27 authorities in real time.

START FREE →

TERMES CONNEXES

Clearance 510(k)Contrôles de conception