Heart valves and pacemakers are classified as what type of medical device?

Heart valves and pacemakers are classified as Class III medical devices because they are used to support or sustain human life, and their failure could lead to significant risk of injury or illness. Class III devices typically include those that are critical for the health and safety of patients, requiring the highest level of regulatory oversight.

The classification process for medical devices by the FDA categorizes them based on the level of risk associated with their use. Class III devices are subject to more stringent requirements, including the necessity for premarket approval that includes scientific evidence of safety and effectiveness. This rigorous evaluation is crucial for devices that interact directly with the cardiovascular system, like heart valves, and those that regulate heart rhythm, such as pacemakers.

In contrast, Class I and Class II devices typically involve lower levels of risk and thus have less stringent regulatory requirements. Class I devices are generally considered to be low-risk and usually subject only to general controls, while Class II devices are moderate-risk and require both general and special controls. Class IV devices is not a recognized classification in the commonly used regulatory framework.