A humanitarian device is a medical device specially designated by the US Food and Drug Administration (FDA) for use in the treatment of a rare medical condition (fewer than 4000 new cases per year in the United States). The FDA requires that any physician who wishes to use the device to treat a patient must first obtain approval from the hospital’s institutional review board. The Medtronic Enterra™ Therapy system was designated as a device for humanitarian use by the FDA in 1999.
After Enterra Therapy was designated for humanitarian use, Medtronic submitted a Humanitarian Device Exemption (HDE) application to the FDA. This type of application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. However, it must contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Also, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that the applicant could not otherwise bring the device to market. Once the FDA approved the Humanitarian Device Exemption in 2000, Medtronic was able to manufacture and distribute Enterra Therapy in the United States.