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U-MIC

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

3. 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
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4. 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
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5. 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
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U-MIC

6. 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
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U-MIC

7. 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
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U-MIC

8. Humanitarian Use Devices (HUDs)
HUD guidance:
HUD informed consent template:
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U-MIC

9. thank you.
Brian Seabolt
IRBMED
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U-MIC