Permission to treat a patient with a humanitarian use device (HUD) allows doctors to use a HUD before it has Food and Drug Administration (FDA) approval.
Doctors can use the HUD to treat or diagnose a disease or condition that affects fewer than 8,000 individuals in the United States per year. A HUD can be used only when no comparable, FDA-approved device is available. A HUD allows patient care, not for research purposes.
If you want to use a HUD for a research study, you should submit the Aurora IRB Protocol Submission Form. See our research forms.
The FDA can grant a humanitarian device exemption (HDE) to device manufacturers. With an HDE, companies can market a HUD before research has proven its effectiveness. There must be evidence that the HUD is not likely to cause harm to patients.
An IRB must approve your HUD request before you use the HUD to treat a patient at Aurora. Under an approved HUD request, it is expected that you use the device to treat a patient according to its approved labeling and indications.
Off-label use of HUDs is part of the treatment plan for a patient as part of the physician’s practice of medicine. Such uses do not require submission to the Aurora IRB.
Before submitting an application for IRB review of a humanitarian use device, please review the following information:
After you have reviewed the above information, you may proceed with your application for IRB review of a humanitarian use device.
To ask our IRB to review your request to use a HUD in patient care, please download and submit the following forms:
After using the HUD, you’ll submit a final report to our IRB. With the same form, you can request continuing use of the HUD beyond the approval period. Download HUD Application for Continuing Review/Final Report [DOC].