类别: REGULATORY PATHWAYS

人道主义器械豁免(HDE)

FDA为治疗或诊断美国每年影响少于8,000名患者的疾病的器械设立的途径。HDE不要求有效性数据，但要求可能的获益。

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

Confirm rare-condition population estimate.
Prepare HDE application and IRB considerations for use.
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

FDA HDE ↗

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