significant and nonsignificant risk devices

1. 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. Developed by: U-MIC

2. significant and nonsignificantrisk devices in human subjects research Developed by: U-MIC University of Michigan IRB Collaborative

3. significant risk device • Significant risk device means an investigational device that: • Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; • 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; • 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 • Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. Significant and nonsignificant risk devices Developed by: U-MIC

4. significant risk device • Significant risk device means an investigational device that: • Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; • 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; • 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 • Otherwisepresents a potential for serious risk to the health, safety, or welfare of a subject. Significant and nonsignificant risk devices Developed by: U-MIC

5. nonsignificant risk device • A nonsignificant risk device study is one that does not meet the definition for a significant risk device study. Significant and nonsignificant risk devices Developed by: U-MIC

6. Significant and nonsignificant risk devices • diagnosing • curing • mitigating • treating may be significant (presents a potential for serious risk) or nonsignificant (does not present a potential for serious risk) Developed by: U-MIC

7. 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 Significant and nonsignificant risk devices Developed by: U-MIC

8. 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 Significant and nonsignificant risk devices Developed by: U-MIC

9. significant risk device studies • 21 CFR 812 • investigational device exemption (IDE) • FDA approves IDE • IRB approves study Significant and nonsignificant risk devices Developed by: U-MIC

10. 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 Significant and nonsignificant risk devices .2(b) • records • reports • prohibition against promoting or marketing Developed by: U-MIC

11. IRB review • device and proposed use of device • convened IRB meeting • relevant information • description • past research • study plan • subject selection Significant and nonsignificant risk devices • meeting minutes should indicate determination • rationale • documentation • IDE approval letter • FDA’s nonsignificant risk determination Developed by: U-MIC

12. IRB review Significant and nonsignificant risk devices • 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 Developed by: U-MIC

13. IRB review Significant and nonsignificant risk devices • 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 Developed by: U-MIC

14. significant nonsignificant risk device studies Significant and nonsignificant risk devices Developed by: U-MIC

15. Brian Seabolt IRBMED thank you. Developed by: U-MIC