Which class of device is considered low-risk and requires general controls?

The classification of medical devices is primarily determined by the level of risk associated with their use and the controls necessary to ensure their safety and effectiveness. Class I devices are recognized as low-risk devices and are subject to general controls that ensure their safety and effectiveness.

General controls for Class I devices typically include provisions related to establishment registration, device listing, manufacturing practices, labeling requirements, and reporting requirements for adverse events. These devices are often simple in design and generally do not require premarket approval or notification, making the regulatory pathway less burdensome.

In contrast, Class II and Class III devices are associated with higher risks and require more stringent regulatory controls. Class II devices may require special controls in addition to general controls, such as premarket notification (510(k)), while Class III devices are those that support or sustain human life, present a potential unreasonable risk of illness or injury, and typically require premarket approval due to their higher complexity and risk profile.

Understanding the classification system is crucial for regulatory affairs professionals, as it guides the regulatory strategy and compliance efforts for different types of medical devices. Thus, Class I devices stand out as low-risk options within this framework, necessitating only general controls to ensure their safe market presence.