Humanitarian Device Exemption

FDA marketing pathway for devices treating rare conditions affecting fewer than 8,000 U.S. patients per year.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

An HDE is an application similar to a PMA but exempt from the effectiveness requirements. It allows marketing of a Humanitarian Use Device (HUD) intended to benefit patients with rare diseases or conditions.

What this means in practice

HDE devices must demonstrate probable benefit outweighs risk of injury or illness. Use is generally restricted, often requiring IRB oversight, and there are profit limitations except in pediatric cases.

Primary references

3 sources

Link health: 3 verified· last checked 2026-05-09

FDA·1European Commission·1IMDRF·1

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On this term

Category: Regulatory
Acronym: HDE
Sources: 3
Updated: 5/5/2026

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FDA marketing pathway for devices treating rare conditions affecting fewer than 8,000 U.S. patients per year.

·HDE devices must demonstrate probable benefit outweighs risk of injury or illness.
·Use is generally restricted, often requiring IRB oversight, and there are profit limitations except in pediatric cases.
·It allows marketing of a Humanitarian Use Device (HUD) intended to benefit patients with rare diseases or conditions.

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FDA marketing pathway for devices treating rare conditions affecting fewer than 8,000 U.S. patients per year.

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