U.S. FDA Releases Draft Guidance on Humanitarian Device Exemptions

The U.S. Food and Drug Administration (FDA) has published a draft guidance to clarify its requirements and review practices in connection with medical device applications submitted under its Humanitarian Device Exemption (HDE) Program.

According to the FDA, humanitarian use devices (HUDs) are “medical devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or are manifested in not more than 8000 individuals in the United States per year.” The FDA’s HDE Program is intended to support the introduction of new and innovative devices for the treatment of such diseases or conditions by granting an exemption from the effectiveness requirements generally applicable to all other medical devices.

However, the HDE is limited to those circumstances in which no comparable device other than one approved under an HDE would be available to diagnose or treat the targeted disease or condition. Further, devices which receive such an exemption must “not expose patients to an unreasonable or significant risk of illness or injury, and the probable benefit to health…outweighs the risk of injury or illness from its use.”

Read the complete text of the FDA’s draft guidance on its HDE Program for medical devices.

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