Humanitarian Device Exemption

An HDE/HUD is a limited form of approval for a device that is intended to treat a rare condition. Specifically, a “medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.” For more information about HDEs visit:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/default.htm

To gain approval for an HDE at Tampa General Hospital, the following forms must be submitted:

  1. HDE Checklist WORD Document
  2. USF IRB Forms
  3. TGH Study Application WORD Document
  4. TGH HDE Information Sheet WORD Document
  5. TGH Device/Procedure Data Sheet WORD Document