SOCRA CCRP Practice Exam 2025 – 400 Free Practice Questions to Pass the Exam

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Who determines whether a device trial is Significant Risk, Non-Significant Risk or exempt?

Sponsor/investigator > IRB > FDA

The sponsor/investigator, IRB, and FDA all play a role in determining the risk level of a device trial. The sponsor/investigator is responsible for submitting the device trial to the IRB for review and determining the initial risk level classification. The IRB then conducts a review and may make a recommendation to change the risk level. The FDA makes the final determination after reviewing the IRB's recommendation and other relevant information. Option B is incorrect because the FDA does not make the decision alone without input from the sponsor/investigator and IRB. Option C and D are incorrect because both the sponsor/investigator and IRB are involved in the process of determining the risk level.

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FDA alone

IRB alone

Sponsor/investigator alone

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