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CATÉGORIE: REGULATORY PATHWAYS

510(k) abrégé

Une soumission 510(k) s'appuyant sur des normes reconnues par 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

An Abbreviated 510(k) relies on guidance documents, special controls, and/or voluntary consensus standards to streamline demonstration of substantial equivalence.

PROCESS / STEPS

  1. Identify applicable FDA guidance and recognized standards.
  2. Provide summary reports and declarations of conformity.
  3. Address any residual differences vs predicate.
  4. Submit and respond to FDA questions.

EXAMPLES

  • Devices with well-established product codes and standards often benefit from abbreviated documentation strategies.

RELATED GUIDES & TOOLS

SOURCES

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TERMES CONNEXES

Clearance 510(k)ISO 13485