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

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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


Humanitarian use devices hud s

Humanitarian use devices right corner of your screen. The presentation will begin after the screen changes and you press (HUDs)

Developed by:

U-MIC

University of Michigan IRB Collaborative


H right corner of your screen. The presentation will begin after the screen changes and you press umanitarian 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


HUD uses right corner of your screen. The presentation will begin after the screen changes and you press

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


investigational use of a HUD right corner of your screen. The presentation will begin after the screen changes and you press

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


HUDs in clinical care right corner of your screen. The presentation will begin after the screen changes and you press

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


HUDs in clinical care right corner of your screen. The presentation will begin after the screen changes and you press

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


Humanitarian Use right corner of your screen. The presentation will begin after the screen changes and you press 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


Thank you

Brian Seabolt right corner of your screen. The presentation will begin after the screen changes and you press

IRBMED

thank you.

Developed by:

U-MIC


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