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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).

If you are looking for any further assistance for HDE, we can help. Please contact us today.

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