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What is a Humanitarian Use Device (HUD)?The HUD regulations were first established in October 1994. Humanitarian Use Devices (HUDs) are medical devices specially designated by the FDA for use in the treatment of rare medical conditions (<4000 per year). The Medtronic Enterra Therapy system was designated a humanitarian Use Device by the FDA in the fall of 1999, and approval of the Humanitarian Device Exemption allows Medtronic to manufacture and distribute this Humanitarian Use Device. Physicians who wish to use the Enterra Therapy under HUD guidelines, must first obtain approval from their hospital Internal Review Board (IRB). An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The application, however, must contain sufficient information for 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. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm#1 What is Humanitarian Device Exemption (HDE)?Enterra Therapy received humanitarian device exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) in 2000. HDE status allows Medtronic, Inc. to provide the Enterra Therapy System for the treatment of drug-refractory nausea and vomiting associated with gastroparesis of diabetic or idiopathic origin. Because of the HDE status, the system must be implanted in a medical center whose institutional review board (IRB) has approved use of the device. 
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