Which of the following describes Class III devices?

Class III devices are those that are subject to the most stringent regulatory controls due to their potential risk to patients. These devices are typically used in situations where they may support or sustain human life, or present a potential unreasonable risk of illness or injury. To ensure safety and effectiveness, Class III devices require premarket approval from the FDA. This process typically involves clinical trials that provide evidence of the device’s safety and effectiveness in the intended population.

The requirement for premarket approval means that the manufacturer must submit a premarket approval application (PMA) that includes data from clinical trials, detailing the device's performance and safety profile. This rigorous process distinguishes Class III devices from those in lower classes that may only require general controls or may not need premarket approval at all. The necessity of clinical trials in the approval process reflects the higher stakes associated with these devices, ensuring that they are thoroughly evaluated before being made available to patients.