SOCRA CCRP Practice Exam

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What is the regulatory process if a device meets even one criterion for exemption?

IRB review and approval, no FDA notification
FDA review and approval, then IRB
Direct FDA approval
Both FDA and IRB review concurrently

The correct answer is: IRB review and approval, no FDA notification

If a device meets even one criterion for exemption, it means that the device does not need to go through the FDA review and approval process. Instead, the device can go through IRB review and approval. Option B is incorrect because it suggests that the device would still need to go through FDA review and approval before going through IRB review. Option C is incorrect because it suggests that the device would only need FDA approval and not IRB approval, which is not the case for exemption. Option D is incorrect because it suggests that both the FDA and IRB would need to review the device concurrently, which is not necessary for exemption. In summary, option A is the correct answer because it accurately explains the regulatory process for devices that meet even one criterion for exemption.