SOCRA CCRP Practice Exam

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What is the definition of a Non-Significant Risk device?

Does not meet criteria of a significant risk device
Is of minimal risk
Requires FDA approval before study
Is for temporary external use

The correct answer is: Does not meet criteria of a significant risk device

A non-significant risk device is one that does not meet the criteria of a significant risk device. This means that it does not pose a significant risk to the health, safety, or wellbeing of the patient. Option B is incorrect because "minimal risk" is not a defined term in this context. Option C is incorrect because all medical devices require FDA approval before being marketed in the US. Option D is incorrect because the temporary or external use of a device does not determine its risk classification.