SOCRA CCRP Practice Exam

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What is the key regulatory difference between SR and NSR device reviews?

SR requires FDA and then IRB approval; NSR requires only IRB approval
NSR requires FDA approval; SR does not
Both require FDA approval, but at different stages
IRB approval is only needed for SR studies

The correct answer is: SR requires FDA and then IRB approval; NSR requires only IRB approval

The key regulatory difference between SR and NSR device reviews is that with SR studies, both FDA and IRB approval are required, while with NSR studies, only IRB approval is needed. Option B is incorrect because NSR studies may not require FDA approval. Option C is incorrect because both SR and NSR studies require FDA approval, but at different stages - FDA approval is required before starting an SR study, while it is only needed for NSR studies if there are significant modifications. Option D is incorrect because IRB approval is still required for NSR studies, just not FDA approval.