Humanitarian Use Devices (HUDs)
The Humanitarian Use Devices (HUDs) listed in this table have all been approved by the UW IRB for clinical use at UW Medicine. HSD does its best to keep this table up-to-date, by adding HUDs described in new IRB applications and removing HUDs that later receive full FDA approval (“premarket approval”, or PMA).
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; email@example.com) 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: firstname.lastname@example.org 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: email@example.com 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|
|Transcatheter Septal Occluder||Transcatheter Septal Occluder||AMPLATZERTM Post-Infarct Muscular VSD Occluder||H070005||Abbott Medical|
|Coronary covered stent||Coronary covered stent||PK Papyrus Covered Coronary Stent System||H170004||Biotronik, Inc.|
|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||PulseRider Aneurysm Neck Reconstruction Device||H160002||Pulsar Vascular|
|Cultured epithelial autograft||Cultured epithelial autograft||Epicel (cultured epidermal autografts)||H990200||Vericel|