What is the primary difference between a Class I and Class III medical device?

The primary difference between a Class I and Class III medical device lies in the level of risk associated with each classification. Class I devices are categorized as low risk and typically include items that pose minimal threat to patients when used correctly, such as band-aids or handheld surgical instruments. These devices usually have a straightforward regulatory pathway that often involves general controls to ensure safety and effectiveness.

In contrast, Class III devices are considered high risk and often involve more complex technologies or are critical to sustaining life, like implantable devices, pacemakers, or major diagnostic devices. Because of their potential impact on patient health and safety, Class III devices require rigorous pre-market approval processes, including comprehensive clinical trials to demonstrate their safety and effectiveness before they can be marketed.

This classification system ensures that higher-risk devices undergo a more thorough evaluation process compared to lower-risk devices, reflecting the varying levels of risk associated with their use.