A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects no more than 8,000 individuals per year in the United States. Under 21 CFR 814.124, Institutional Review Boards (IRBs) are required to approve the use of a Humanitarian Use Device (HUD), except in emergency situations, for an institution to deliver the device to patients. In addition to the initial approval, IRBs must perform continuing review of a HUD application at least yearly. Requires an approved HDE from FDA. Requires prior IRB approval, but is not considered research.
Submit the following forms to IRBmail@uthscsa.edu for IRB review and approval:
- HUD Initial Request Form
- Form P - Use of Investigational Device Form
- Copy of package insert or FDA approved label (PDR reference)