IRB Reviewer Checklist for HUD Initial Review
IRB ID Number
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Humanitarian Use Device Title
*
Reviewer Name
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First Name
Last Name
Email
Reviewers should consider use of the device considering the following criteria
Does the physician propose to use the device according to its FDA approved labeling and indications to treat or diagnose patients?
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Yes
No
Is the expected number of devices to be used annually at BRG appropriate?
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Yes
No
Have risks to patients found in product labeling or annual report been reviewed?
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Yes
No
Have risks been minimized?
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Yes
No
Are risks reasonable in relation to the proposed use of the device?
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Yes
No
Does the HDE holder require the physician or staff to be trained on use of the device?
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Yes
No
Was a patient information packet reviewed?
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Yes
No
Was an informed consent reviewed?
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Yes
No
Should an informed consent be required?
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Yes
No
Are the product labeling and IRB application congruent? Are they both accurately reflected in the patient information/informed consent?
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Yes
No
Do you recommend any limitations on the use of the device?
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Yes
No
Check all that apply
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Specific measures of disease progression
Prior use and failure of any alternative treatment modalities
Specific reporting requirements to IRB
Appropriate follow-up precautions and evaluations
Other (please include in comments below)
Comments
Reviewer Signature
Today's Date
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Month
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Day
Year
Date
SUBMIT
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