Humanitarian Use Device program came into existence in 1990 under the Safe Medical Device Act. This program allows getting market approval for medical devices that deliver benefits to patients in treatment and diagnosis of rare diseases or medical conditions that impact fewer than 4000 individuals in the United States per year. In December 2016, the population benchmark was changed from fewer than 4000 individuals to not more than 8000 individuals to qualify for the HUD program under 21st Century Cures Act, section 3052. To obtain an HUD approval for a rare condition medical device, an applicant must prove that the device meets the definition, and also provide relevant reference documents describing disease or condition that the device can address, proposed usage, indications and a reason for the need of developing such a medical device.
