If a sponsor of a Non-Significant Risk (NSR) device wants to perform an investigation, they assess the device as NSR then proceed to get the concurrence of the IRB on this determination.
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Get it written →If a sponsor of a Non-Significant Risk (NSR) device wants to perform an investigation, they assess the device as NSR then proceed to get the concurrence of the IRB on this determination. There are many instances of IRB fraud. Why do you think the FDA still allows this process given past experiences with shady IRBs?
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