How are Class I medical devices characterized in terms of risk?

Class I medical devices are characterized as generally low risk and are subject to the least regulatory control among the different classes of medical devices. This classification includes items like bandages, some handheld surgical instruments, and non-electric wheelchairs. These devices typically pose minimal potential harm to patients and are often subject to general controls, such as good manufacturing practices and labeling requirements, rather than the extensive premarket approval processes required for higher-risk classes.

The classification reflects a balanced approach to ensuring safety and effectiveness while allowing for easier access to market for low-risk devices, which can promote healthcare innovation and access without compromising patient safety.