Humanitarian Use Devices (HUDs)
There are unique billing and other compliance considerations associated with the use of HUDs. Once approved by HSD, HUD applicants must contact UW Medicine Compliance (206.543.3098; firstname.lastname@example.org) to discuss these aspects.
See below for more information, including what to do if you wish to use a HUD that has not been approved by the UW IRB.
Clinical use, emergency (on-label or off-label)
- If the HUD has been approved by the UW IRB (see list below): no interaction with HSD or the IRB is required.
- If the HUD has not been approved by the UW IRB: follow the instructions provided at this HSD webpage
Clinical use, not emergency (on-label or off-label)
- If the HUD has already been approved by the UW IRB (see list below): no interaction with HSD or the IRB is required
- If the HUD has not been approved by the UW IRB: submit an IRB application or (if it is an emergency), follow the instructions at this HSD web page.
- If repeated off-label uses are expected: the existing UW IRB application for the HUD should be modified for general off-label use. This does not require obtaining approval from the FDA. Contact HSD for assistance: email@example.com or contact the HSD Team Operations Lead for your department: find your HSD department contact
You must obtain IRB approval in advance, even if the HUD is already approved for clinical use at the UW.
- Read Section 6 (one page) of HSD’s SOP Humanitarian Use Device
- Submit an IRB application through the Zipline e-IRB system
- You must obtain an IDE from the FDA if you are studying the HUD for an indication that is not the HDE-approved indication (i.e., off-label).
- Contact HSD if you any questions: firstname.lastname@example.org or contact the HSD Team Operations Lead for your department: find your HSD department contact
|Classification Name||Generic Name||Trade Name||HDE Number||HDE holder|
|Coronary covered stent||Coronary covered stent||PI Papyrus Covered Coronary Stent System||H170004||Biotronik, Inc.|
|Coronary covered stent||Coronary covered stent||Jomed Jostent Coronary Stent Graft||H000001||Abbott Vascular Devices|
|Intracranial neurovascular stent||Intracranial neurovascular stent||Neuroform Microdelivery Stent||H020002||Stryker Neurovascular|
|Implanted subcortical electrical stimulator (motor disorders)||Implanted subcortical electrical stimulator (motor disorders)||Medtronic Activa Deep Brain Stimulation (DBS) System||H020007||Medtronic Neuromodulation|
|Intracranial neurovascular stent||Intracranial neurovascular stent||Wingspan Stent System with Gateway PTA Balloon Catheter||H050001||Stryker Corp.|
|Deep brain stimulator for obsessive compulsive disorder (OCD)||Deep brain stimulator for obsessive compulsive disorder (OCD)||Metronic (Activa) Deep Brain Stimulation for OCD Therapy||H050003||Medtronic, Neurological Division|
|Intracranial neurovascular stent||Intracranial neurovascular stent||Codman Enterprise Vascular Reconstructive Device and Delivery System||H060001||Codman & Shurtleff|
|Intracranial neurovascular stent||Intracranial neurovascular stent||LVIS Intralumijnal Support Device||H130005||MicroVention, Inc|
|Right ventricular bypass (assist) device||Right ventricular bypass (assist) device||Impella RP System||H140001||Abiomed, Inc|
|Intracranial neurovascular stent||Intracranial neurovascular stent||PulseRider Aneurysm Neck Reconstruction Device||H160002||Pulsar Vascular|
|Microspheres radionuclide||Mircospheres radionuclide||MDS Nordion Therasphere Yttrium-90 Glass Microspheres||H980006||Biocompatibles U.K. Limited|
|Cultured epithelial autograft||Cultured epithelial autograft||Epicel (cultured epidermal autografts)||H990200||Vericel|