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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 1

HUMANITARIAN USE DEVICES (HUDs) Developed by: U-MIC University of Michigan IRB Collaborative

HUDs Humanitarian Use Device a medical device 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 21 CFR 814. 3(n) • only probable benefit • IRB oversight • clinical care (HUD application in e. Research) • research (standard application in e. Research) Developed by: U-MIC 3

HUDs HUD uses • clinical care for approved indication • off-label in clinical care (emergency use) • safety and effectiveness data • new 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 Investigational Device Exemption (IDE) • issued by IRB or FDA Developed by: U-MIC 4

investigational use of a HUDs • submit standard e. Research 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 5

HUDs in clinical care reporting HUDs adverse events • within 14 days, physician or HDE holder submits Medical Device Report (MDR) to both FDA and IRB ü Does HUD appear to have caused or contributed to death or serious injury*? ü 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 6

HUDs in clinical care reporting Ø reports to or from FDA Ø reports to or from sponsor, manufacturer, or HDE holder • urgent safety concerns • changes in HUD use Ø breaches of confidentiality Ø routine reports to or from sponsor or manufacturer • do not involve urgent safety issues • do not call for changes in HUD use Developed by: U-MIC HUDs submit to IRB within seven days submit to IRB at scheduled continuing review 7

HUDs Humanitarian Use Devices (HUDs) HUD guidance: https: //research. medicine. umich. edu/office-research/institutionalreview-boards-irbmed/guidance/humanitarian-use-device-requirementsum-physicians-and-investigators HUD informed consent template: https: //research. medicine. umich. edu/office-research/institutionalreview-boards-irbmed/informed-consent-templates/specialty-informedconsent-templates#hud Developed by: U-MIC 8

THANK YOU. Brian Seabolt IRBMED Developed by: U-MIC 9