To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC

Humanitarian use devices (HUDs) Developed by: U-MIC University of Michigan IRB Collaborative

Humanitarian Use Device HUDs Humanitarian Use Device a medical device 21 CFR 814.3(n) only probable benefit IRB oversight clinical care (HUD application in eResearch) research (standard application in eResearch) intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year Developed by: U-MIC

HUD uses HUDs clinical care for approved indication Humanitarian Device Exemption (HDE) issued by FDA HDE holder may be manufacturer or physician no risk/benefit assessment for clinical care after IRB approves HUD application, physician does not need approval for each individual use of device clinical care for approved indication off-label in clinical care (emergency use) safety and effectiveness data new indication Investigational Device Exemption (IDE) issued by IRB or FDA Developed by: U-MIC

investigational use of a HUD HUDs investigational use of a HUD submit standard eResearch application non-significant risk IRB may grant IDE significant risk FDA must grant IDE off-label HUD use generally considered significant risk Developed by: U-MIC

HUDs in clinical care reporting HUDs adverse events *serious injury: within 14 days, physician or HDE holder submits Medical Device Report (MDR) to both FDA and IRB Does HUD appear to have caused or contributed to death or serious injury*? Does HUD appear to have malfunctioned and might reoccurrence cause or contribute to death or serious injury? *serious injury: life-threatening permanent impairment of body function permanent damage to body structure medical/surgical intervention to preclude permanent impairment of body function medical/surgical intervention to preclude permanent damage to body structure Developed by: U-MIC

HUDs in clinical care reporting HUDs submit to IRB within seven days reports to or from FDA reports to or from sponsor, manufacturer, or HDE holder urgent safety concerns changes in HUD use breaches of confidentiality routine reports to or from sponsor or manufacturer do not involve urgent safety issues do not call for changes in HUD use submit to IRB within seven days submit to IRB at scheduled continuing review Developed by: U-MIC

Humanitarian Use Devices (HUDs) HUD guidance: http://www.med.umich.edu/irbmed/guidance/HUD.html HUD informed consent template: http://www.med.umich.edu/irbmed/ict.htm#hud Developed by: U-MIC

thank you. Brian Seabolt IRBMED Developed by: U-MIC