SOCRA CCRP Practice Exam

The three types of medical device studies as defined under Investigational Device Exemptions (IDE) regulations are indeed significant risk, non-significant risk, and exempt. This classification is essential because it helps determine the level of regulatory requirements and oversight necessary for each category, thereby ensuring the safety and ethical considerations in medical device research.

"Significant risk" devices are those that pose a potential for serious risk to the health, safety, or welfare of a subject. Research studies involving these devices require an IDE submission, which means they must undergo rigorous FDA review before proceeding.

"Non-significant risk" devices, in contrast, are deemed to present a lesser risk to subjects, and while they still require some level of regulation, the IDE requirements are less stringent. This classification helps streamline the research process for studies that are considered lower risk and can facilitate easier access to clinical trials.

"Exempt" studies refer to devices that do not require an IDE application because they are considered to present no risk to patients. These would typically involve devices that are already legally marketed for their intended use or fall into categories specified by regulation.

The other options presented do not accurately reflect the framework established under IDE regulations, which specifically focuses on the risk assessment of devices being tested in clinical