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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 • 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 v FDA-approved IDE not required v 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 description past research study plan subject selection Developed by: U-MIC • meeting minutes should indicate determination o rationale o documentation Ø Ø IDE approval letter FDA’s nonsignificant risk determination 11
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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