SOCRA CCRP Practice Exam

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What are the three types of medical device studies listed under IDE regulation?

Significant risk, Non-significant risk, Exempt
Minor risk, Major risk, Non-applicable
Clinical trial, Preclinical trial, Post-market
Observational, Investigational, Controlled

The correct answer is: Significant risk, Non-significant risk, Exempt

The other options listed are not the types of medical device studies listed under IDE regulation. Option B refers to the level of risk involved in the study, while options C and D refer to different types of trials. Option A is correct because it accurately lists the three types of medical device studies covered under IDE regulation significant risk, non-significant risk, and exempt. A significant risk study involves a device that poses potential harm to the patient, while a non-significant risk study involves a device with minimal risk. Exempt studies do not need to go through the IDE process because they do not pose any potential risk to patients.