Slide 1

Slide 2 1 Developed by: U-MIC 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. Slide 3 SIGNIFICANT AND NONSIGNIFICANT RISK DEVICES in human subjects research Developed by: U-MIC University of Michigan IRB Collaborative Slide 4 Significant and nonsignificant risk devices 3 Developed by: U-MIC 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. Slide 5 Significant and nonsignificant risk devices 4 Developed by: U-MIC 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. Slide 6 Significant and nonsignificant risk devices 5 Developed by: U-MIC nonsignificant risk device A nonsignificant risk device study is one that does not meet the definition for a significant risk device study. Slide 7 Significant and nonsignificant risk devices 6 Developed by: U-MIC diagnosing curing mitigating treating may be significant (presents a potential for serious risk) or nonsignificant (does not present a potential for serious risk) Slide 8 Significant and nonsignificant risk devices 7 Developed by: U-MIC significant risk device intraocular lens implanted surgically presents a potential for serious risk nonsignificant risk device daily-wear contact lens worn on eyes surface does not present a potential for serious risk Slide 9 Significant and nonsignificant risk devices 8 Developed by: U-MIC FDAs determination supersedes both sponsors and IRBs determinations IRBs determination supersedes sponsors determination sponsors determination included, with rationale, in IRB application Slide 10 Significant and nonsignificant risk devices 9 Developed by: U-MIC significant risk device studies 21 CFR 812 investigational device exemption (IDE) FDA approves IDE IRB approves study Slide 11 Significant and nonsignificant risk devices 10 Developed by: U-MIC nonsignificant risk device studies 21 CFR 812 abbreviated device study regulations labeling IRB approval informed consent monitoring FDA-approved IDE not required IRB serves as FDA surrogate records reports prohibition against promoting or marketing Slide 12 Significant and nonsignificant risk devices 11 Developed by: U-MIC IRB review device and proposed use of device convened IRB meeting relevant information o description o past research o study plan o subject selection meeting minutes should indicate determination o rationale o documentation IDE approval letter FDAs nonsignificant risk determination Slide 13 Significant and nonsignificant risk devices 12 Developed by: U-MIC IRB review nonsignificant risk applies only to device studies expedited review of device studies nonsignificant risk device study minimal risk study minimal risk criterion for expedited review Slide 14 Significant and nonsignificant risk devices 13 Developed by: U-MIC IRB review study review and approval risk/benefit assessment significant or nonsignificant risk device determination before study review and approval potential harm of device or its use Slide 15 Significant and nonsignificant risk devices 14 Developed by: U-MIC significant nonsignificant risk device studies Slide 16 THANK YOU. Brian Seabolt IRBMED 15 Developed by: U-MIC