Task list for off-label use of Humanitarian Device Exemption (HDE)–Approved Devices (2)
| Emergent HDE Off-Label Use* | Compassionate HDE Off-Label Use† |
|---|---|
| Obtain IRB chairperson's concurrence. If unable to obtain, must report within 5 days. | Provide HDE holder (company) with the following: A description of the patient's condition. |
| Obtain informed consent of patient or legal representative, if possible. | The circumstances necessitating the use of the device. |
| Provide documentation of independent assessment by uninvolved physician (not referring physician). | A discussion of why alternative therapies of diagnostics are unsatisfactory. |
| Obtain institutional clearance, written notice that the IRB acknowledges the off-label use. | A follow-up plan to HDE holder for their submission to the FDA. |
| Obtain authorization from HDE holder (company). | FDA approved for compassionate use with help of HDE holder.‡ |
| Obtain submission of a follow-up plan to HDE holder for their submission to the FDA. |
Note:—IRB indicates Institutional Review Board; FDA, US Food and Drug Administration.
* Emergent HDE use: to save life or protect the physical well-being of a patient.
† Compassionate HDE: not an emergency, but no alternative device for the patient's condition exists.
‡ This task is a requirement, whereas all other tasks listed for both emergent and compassionate use are recommendations.