UW Research

humanitarian use device

A medical device (1) intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in no more than 8,000 individuals in the United States per year, and (2) that has been granted Humanitarian Device Exemption status by the Food and Drug Administration (FDA). There are fewer FDA requirements for approval of these devices to encourage manufacturers’ research and development of medical devices for use with limited populations. See also: humanitarian device exemption