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FDA Approves Mechanical Cardiac Assist Device for Children With Heart Failure
Date:12/16/2011

d of care, although not FDA approved. Stroke, which can cause serious brain deficits, is a risk of the EXCOR Pediatric System.  

The EXCOR was designated as a Humanitarian Use Device (HUD) by the Office of Orphan Products Development at the FDA. This designation is for medical devices intended to benefit patients in the treatment or diagnosis of a disease or condition that affects fewer than 4,000 individuals in the United States annually. The device was approved under a Humanitarian Device Exemption (HDE), a type of marketing application that is similar to a premarket approval application in that the level of safety required for approval is the same. Rather than having to show a reasonable assurance of effectiveness, devices submitted under the HDE marketing route need to prove that the probable benefit from use of the device outweighs the probable risk of illness or injury from its use to obtain the FDA's approval.

The FDA approval of an HDE authorizes an applicant to market the device subject to certain use restrictions. After the passing of the Pediatric Medical Device Safety and Improvement Act of 2007, HUDs intended and labeled for use in a pediatric population are permitted to be marketed for profit.  

The FDA's Orphan Products Grant Program supported the U.S. clinical trials for the EXCOR Pediatric System with grants of $400,000 per year for three years.

For more information:

Designating Humanitarian Use Devices
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/DesignatingHumanitarianUseDevicesHUDS/default.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human u
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SOURCE U.S. Food and Drug Administration
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