What type of device presents a potential for serious risk to the health or safety of subjects?

A Significant Risk (SR) device is classified as a medical device that poses a potential for serious risk to the health or safety of subjects. This classification is crucial within the context of human subject research because it dictates the necessary regulatory requirements for conducting clinical trials. The U.S. Food and Drug Administration (FDA) defines a significant risk device as one that is intended for use in a clinical investigation and is anticipated to have a serious impact on a patient's health or well-being.

When a device is classified as significant risk, it requires a full Investigational Device Exemption (IDE), which means it must undergo more rigorous oversight, including pre-study review and approval from an Institutional Review Board (IRB) to ensure that the rights and safety of participants are adequately protected. This oversight is critical in clinical trials to minimize the risks involved and ensure that the benefits outweigh those risks.

In contrast, other device classifications mentioned, such as Non-Significant Risk (NSR) devices, do not present the same level of risk and therefore go through a less stringent regulatory pathway. Humanitarian Use Devices (HUD) are used to treat conditions that affect relatively small patient populations, and while they may carry risks, they are generally evaluated under different criteria. The Investigational