A medical device that requires pre-marketing approval and must demonstrate safety and effectiveness is classified as which type of device?

The classification of a medical device plays a crucial role in its regulation and approval process. A medical device that requires pre-marketing approval and must demonstrate both safety and effectiveness is classified as Class III.

Class III devices are those that are considered to pose the highest risk to patients and, therefore, are subject to the most stringent regulatory controls. This classification often includes devices that are intended to sustain or support life, are implanted in the body, or present a potential unreasonable risk of illness or injury. Because of the higher stakes associated with these devices, manufacturers must provide extensive evidence through clinical trials to obtain FDA approval, demonstrating that the device is both safe for its intended use and effective in delivering the claimed benefits.

In contrast, Class I devices are generally low-risk, subject to the least regulatory control, and mostly require general controls to ensure safety. Class II devices are moderate-risk devices that require more regulation than Class I but do not undergo the same rigorous pre-market approval process as Class III devices; they often need to demonstrate compliance with specific performance standards. The term "Class IV" is not typically used in the classification system established by the FDA for medical devices.

Thus, the correct classification for a medical device that necessitates pre-marketing approval and requires