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CATÉGORIE: REGULATORY PATHWAYS

Exemption pour dispositif humanitaire (HDE)

Une voie FDA pour les dispositifs destinés à traiter des conditions affectant moins de 8 000 patients par an aux États-Unis.

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

Humanitarian Device Exemption covers devices treating/diagnosing conditions affecting fewer than 8,000 patients/year in the US, with probable benefit rather than full effectiveness proof.

PROCESS / STEPS

  1. Confirm rare-condition population estimate.
  2. Prepare HDE application and IRB considerations for use.
  3. Plan post-approval reporting and HUD limitations on profit in some cases.

EXAMPLES

  • Devices for ultra-rare pediatric conditions may use HDE when PMA is impractical.

RELATED GUIDES & TOOLS

SOURCES

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TERMES CONNEXES

Approbation pré-commercialisation (PMA)Clearance 510(k)