GCP of Devices Practice Test

Significant Risk devices are those that could pose a serious risk to the health or safety of a study participant. They are typically defined by meeting at least one of these conditions: the device is implanted or sustains life, or the device is of substantial importance in diagnosing, curing, mitigating, or treating a disease or condition. Because SR devices carry a meaningful threat to participant welfare, they must be overseen with heightened regulatory scrutiny.

In this context, the statement that a device does NOT pose a significant risk of harm is not a characteristic of a Significant Risk device. By definition, SR devices involve significant risk. The other statements—being implanted or sustaining life, and being very important in diagnosing, curing, or treating disease—are characteristics that align with SR devices, which is why they’re consistent with the concept.