In the context of FDA classification, what typically characterizes Class III devices?

Class III devices are characterized by presenting significant risks to users should they fail. This classification is designed for devices that are often life-sustaining, involve substantial risk of illness or injury, or are intended for use in supporting or sustaining human life. Because of the potential consequences of device failure, Class III devices require the most stringent regulatory controls, including premarket approval by the FDA to ensure safety and efficacy. This regulatory process often involves extensive clinical trials to demonstrate that the device performs as intended without posing undue risk to patients.

In contrast, other classifications relate to devices with either minimal or low risk, such as Class I devices, which are subject to the least regulatory control, and Class II devices, which require moderate regulation. Therefore, the level of risk associated with Class III devices is a critical factor that underpins the regulatory scrutiny they face.