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Humanitarian use devices (HUD s )

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. Humanitarian use devices (HUD s ). H umanitarian U se D evice. HUDs. a medical device 21 CFR 814.3(n )

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Humanitarian use devices (HUD s )

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  1. 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

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

  3. Humanitarian Use Device HUDs • 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

  4. HUD uses HUDs • 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

  5. investigational use of a HUD HUDs • 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

  6. HUDs in clinical care reporting HUDs • adverse events • within 14 days, physician or HDE holder submits Medical Device Report (MDR)to both FDA andIRB • 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

  7. HUDs in clinical care reporting HUDs • 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 IRBwithin seven days submit to IRBat scheduledcontinuing review Developed by: U-MIC

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

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

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