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Developed by:
U-MIC
1
SIGNIFICANT AND
NONSIGNIFICANT
RISK DEVICES
in human subjects research
Developed by:
U-MIC
University of Michigan IRB Collaborative
Significant and nonsignificant risk devices
significant risk device
Significant risk device means an investigational device that:
1) Is intended as an implant and presents a potential for
serious risk to the health, safety, or welfare of a subject;
2) Is purported or represented to be for a use in supporting
or sustaining human life and presents a potential for
serious risk to the health, safety, or welfare of a subject;
3) Is for a use of substantial importance in diagnosing,
curing, mitigating, or treating disease, or otherwise
preventing impairment of human health and presents a
potential for serious risk to the health, safety, or welfare
of a subject; or
4) Otherwise presents a potential for serious risk to the
health, safety, or welfare of a subject.
Developed by:
U-MIC
3
Significant and nonsignificant risk devices
significant risk device
Significant risk device means an investigational device that:
1) Is intended as an implant and presents a potential for
serious risk to the health, safety, or welfare of a subject;
2) Is purported or represented to be for a use in supporting
or sustaining human life and presents a potential for
serious risk to the health, safety, or welfare of a subject;
3) Is for a use of substantial importance in diagnosing,
curing, mitigating, or treating disease, or otherwise
preventing impairment of human health and presents a
potential for serious risk to the health, safety, or welfare
of a subject; or
4) Otherwise presents a potential for serious risk to the
health, safety, or welfare of a subject.
Developed by:
U-MIC
4
Significant and nonsignificant risk devices
nonsignificant risk device
A nonsignificant risk device study is one that does not
meet the definition for a significant risk device study.
Developed by:
U-MIC
5
Significant and nonsignificant risk devices
• diagnosing
• curing
• mitigating
• treating
Developed by:
U-MIC
may be
significant
(presents a potential for serious risk)
or
nonsignificant
(does not present a potential for serious risk)
6
Significant and nonsignificant risk devices
significant risk device
• intraocular lens
• implanted surgically
• presents a potential for serious risk
nonsignificant risk device
• daily-wear contact lens
• worn on eye’s surface
• does not present a potential for serious risk
Developed by:
U-MIC
7
Significant and nonsignificant risk devices
FDA’s determination
•
supersedes both sponsor’s and IRB’s determinations
IRB’s determination
•
supersedes sponsor’s determination
sponsor’s determination
•
included, with rationale, in IRB application
Developed by:
U-MIC
8
Significant and nonsignificant risk devices
significant risk device studies
21 CFR 812
investigational device exemption (IDE)
• FDA approves IDE
• IRB approves study
Developed by:
U-MIC
9
Significant and nonsignificant risk devices
nonsignificant risk device studies
21 CFR 812 .2(b)
abbreviated device study regulations
•
•
•
•
labeling
IRB approval
informed consent
monitoring
• records
• reports
• prohibition against
promoting or marketing
 FDA-approved IDE not required
 IRB serves as FDA surrogate
Developed by:
U-MIC
10
Significant and nonsignificant risk devices
IRB review
• device and proposed use
of device
• convened IRB meeting
• relevant information
o
o
o
o
description
past research
study plan
subject selection
Developed by:
U-MIC
• meeting minutes should
indicate determination
o rationale
o documentation


IDE approval letter
FDA’s nonsignificant risk
determination
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Significant and nonsignificant risk devices
IRB review
nonsignificant risk
minimal risk
• applies only to device studies
• criterion for expedited
review
• expedited review of device studies
• nonsignificant risk device study
• minimal risk study
Developed by:
U-MIC
12
Significant and nonsignificant risk devices
IRB review
study review and
approval
significant or
nonsignificant risk
device determination
• risk/benefit assessment
• before study review and approval
• potential harm of device or its use
Developed by:
U-MIC
13
Significant and nonsignificant risk devices
significant
nonsignificant
risk device studies
Developed by:
U-MIC
14
THANK YOU.
Brian Seabolt
IRBMED
Developed by:
U-MIC
15

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