| Policy | Humanitarian Use Devices |
| DEPARTMENT: | OFFICE FOR HUMAN RESEARCH PROTECTION |
| POLICY NUMBER: | X.C |
| SECTION: | INVESTIGATIONAL DRUGS, BIOLOGICS AND DEVICES |
| REVIEW: | IRB POLICY AND PROCEDURE COMMITTEES |
| EFFECTIVE DATE: | March 19, 2007 |
Subject: Humanitarian Use Devices
Policy:
It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to require that Investigators must comply with all applicable regulations pertaining to humanitarian use devices, and that all uses of humanitarian use devices must be reviewed and approved by the IRB as defined by Federal regulations.
- A Humanitarian Use Device (HUD) that has been granted a Humanitarian Device Exemption (HDE) by FDA may be administered only if such use has been approved by the IRB. If, however, a physician in an emergency situation determines that approval from the IRB cannot be obtained in time to prevent serious harm or death to a patient, a HUD may be administered without prior approval by the IRB. In such an emergency situation, the physician shall, within 5 days after the use of the device, provide written notification to the chairman of the IRB of such use. Such written notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use. [1]
[1] 21 CFR 814.124
