Which of the following must a device have to be classified as a Class III device?

A device is classified as a Class III device primarily because it requires evidence of safety and effectiveness before it can be approved for market use. This classification is reserved for devices that pose a significant risk to patients and/or require a high level of regulatory scrutiny due to their complexity or potential impact on health.

Class III devices are typically those that support or sustain human life, are implanted, or present a potential unreasonable risk of illness or injury. Because of these implications, the FDA mandates that manufacturers of Class III devices conduct clinical trials to generate comprehensive data demonstrating both safety and effectiveness. This requirement ensures that the benefits of the device outweigh any risks associated with its use.

In contrast, devices that require premarket notification align more with Class I and II devices, whereas Class III specifically pertains to those that do not qualify for exemptions from general controls. Additionally, the terminology surrounding clinical trials indicates that Class III devices typically go through rigorous testing, which is essential to guarantee that they are safe and effective for the intended use.