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Re: kayak_wench post# 148097

Thursday, 06/30/2022 2:04:00 PM

Thursday, June 30, 2022 2:04:00 PM

Post# of 181735
From the FDA website for a Nonsignificant Risk Device:

"The FDA considers an investigation of a nonsignificant risk device to have an approved IDE when the IRB concurs with the nonsignificant risk determination and approves the study"

Would you expect less for a Significant Risk Device?
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