Which statement regarding Class III medical devices is true?

Class III medical devices are indeed subject to premarket approval, which is a rigorous process that requires manufacturers to provide significant evidence of the device's safety and effectiveness before it can be marketed. This is necessary because Class III devices are often intended to support or sustain human life, or they may pose a potential risk of illness or injury.

The premarket approval process involves a detailed review by regulatory authorities, such as the FDA in the United States, to ensure that these devices meet specific safety standards. This extensive evaluation ensures that the benefits of using the device outweigh any potential risks, making it essential for devices classified under this category.

In contrast, Class I devices are generally low-risk and subject to the least amount of regulation, often requiring only general controls for safety. Class II devices have additional requirements, such as special controls, but do not require the extensive premarket approval that Class III devices do. Class III devices are not typically considered over-the-counter products; they are usually available only with a prescription due to their complexity and associated risks.