Which type of device study is characterized by minimal risk to patients?

The classification of device studies into Significant Risk (SR) and Non-Significant Risk (NSR) is crucial for understanding the regulatory requirements and the level of risk involved in the study. Non-Significant Risk (NSR) device studies are characterized by minimal risk to patients. This classification is determined by the potential risks associated with the device being tested, which should not be greater than those encountered in daily life or routine clinical practice.

When conducting NSR studies, the regulatory burden is lessened, allowing for more streamlined oversight while still protecting participants' safety and rights. NSR studies typically involve devices that are used in a way that does not pose a significant threat to the patient's health, thereby ensuring ethical conduct in clinical research.

In contrast, Significant Risk (SR) device studies involve greater potential risks and require more rigorous oversight, including a trial's full Investigational Device Exemption (IDE) application to the FDA, which means they are not categorized as minimal risk. Investigational Device Exemption (IDE) studies include both SR and NSR devices but do not specifically denote minimal risk; they refer more broadly to the framework permitting clinical studies of investigational devices. Humanitarian Use Device (HUD) studies are designed for devices that treat or