Humanitarian Use Devices

The FDA requires the IRB to oversee the use of Humanitarian Use Devices (HUDs). Clinical use is limited to indications listed on the product label. The IRB must complete an Initial and Continuing Review of of HUDs. The IRB policies explain additional requirements and list documents that must be included with a submission. Select "Document Library" from the menu on the left-hand side of this page to access IRB policies.