UW Research

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; comply@uw.edu) 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.

HUD Uses

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: hsdinfo@uw.edu or contact the HSD Team Operations Lead for your department: find your HSD department contact

Research use

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: hsdinfo@uw.edu 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
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
Intracranial neurovascular stent Intracranial neurovascular stent Neuroform Microdelivery Stent H020002 PMA approved, 2019 Stryker Neurovascular
Intracranial neurovascular stent Intracranial neurovascular stent LVIS Intralumijnal Support Device H130005 PMA approved, 2017 MicroVention, Inc
Right ventricular bypass (assist) device Right ventricular bypass (assist) device Impella RP System H140001 PMA approved, 2017 Abiomed, Inc
Microspheres radionuclide Microspheres radionuclide MDS Nordion Therasphere Yttrium-90 Glass Microspheres H980006 PMA approval, March 2021 Biocompatibles U.K. Limited