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What are the abbreviated IDE regulations that I am told to follow?

April 26, 2017abbreviated Follow IDE regulations

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What are the abbreviated IDE regulations that I am told to follow?

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An IDE application is not necessary for a NSR device; the IRB acts as the surrogate overseer for the study. The abbreviated IDE regulations specify that certain actions must be taken: proper labeling, clinical trial monitoring, maintenance of research records, submission of reports and obtaining informed consent from volunteer subjects.