What kind of risk does a Class III device represent?

A Class III medical device is categorized as representing a high level of risk. This classification is primarily assigned to devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Due to these factors, Class III devices typically require premarket approval from the FDA, ensuring that they undergo rigorous evaluation for both safety and efficacy. This comprehensive assessment process reflects the heightened level of scrutiny appropriate for devices that could significantly impact patient health and well-being, differentiating them from Class I and Class II devices, which are considered lower risk.