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

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

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