Humanitarian Use Device

A Humanitarian Use DeviceHumanitarian Use Devicea Medical Device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects no more than 8,000 in the United States per year.  (HUD) is a device that is intended to benefitBenefitsomething that promotes or protects well-being, an advantage. Compensation cannot be considered a 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 institutionInstitutionany public or private entity or agency (including federal, state or other agencies).  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 FDAFDAabbreviation for US Food and Drug Administration.  .  Requires prior IRB approval, but is not considered researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.   . 

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 approvedFDA Approvedor cleared refers to FDA having issued premarketing approval (PMA) or cleared the device for marketing via a Premarket Notification 510(k).  label (PDR reference)