HDE (Humanitarian Device Exemption)

HDE (Humanitarian Device Exemption)

Humanitarian Device Exemption – or HDE – provides a regulatory path for Class III devices that are intended to benefit patients with rare diseases or conditions. For a device to be eligible for HDE, a sponsor must obtain designation as a Humanitarian Use Device (HUD), granted through application to the FDA Office of Orphan Products Development (OOPD).

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