RAPS

FDA Clarifies Humanitarian Device Exemption Policies

In response to recent legislative actions, the US Food and Drug Administration (FDA) issued draft guidance to clarify its regulatory review practices for humanitarian device exemptions (HDE). The ...
RAPS

Regulatory Explainer: Making Sense of Humanitarian Use Devices

A new draft guidance document issued Monday by the US Food and Drug Administration (FDA) aims to answer some of the common questions surrounding its 2013 guidance document on humanitarian device ...
Medicine Buffalo

Humanitarian Use Device

A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals ...
Healio

Real-world data: Therapeutic device safe, may benefit sepsis-associated pediatric AKI

Please provide your email address to receive an email when new articles are posted on . The device received FDA humanitarian device exemption status in 2024. Survival rate for children treated with ...