UW IRB Approved Clinical Use 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.
IRB Requirements for HUDs
For clinical use of a HUD, whether emergency or non-emergency and on-label or off-label, see GUIDANCE Humanitarian Use Device, Procedures – Clinical Use of a HUD.
For research use of a HUD, see GUIDANCE Humanitarian Use Device, Procedures – Research Use of a HUD.
|Classification Name||Generic Name||Trade Name||HDE Number||HDE holder|
|Amnioscope, Transabdominal (Fetoscope) (And Accessories)||Amnioscope, Transabdominal (Fetoscope) (And Accessories)||Fetoscopy Instrument Set||H040005||Karl Storz Endoscopy-America, Inc.|
|Coronary covered stent||Coronary covered stent||PK Papyrus Covered Coronary Stent System||H170004||Biotronik, Inc.|
|Transcatheter Septal Occluder||Transcatheter Septal Occluder||AMPLATZERTM Post-Infarct Muscular VSD Occluder||H070005||Abbott Medical|
|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|