What type of devices does the FDA classification system categorize?

The FDA classification system categorizes all medical devices based on their level of risk to patients and users. This system divides devices into three primary classes: Class I (low risk), Class II (moderate risk), and Class III (high risk). Each class has different regulatory requirements that correspond to the potential risk associated with the device's use.

Class I devices are subject to the least regulatory control and must adhere to general controls, while Class II devices require special controls in addition to general controls to ensure safety and effectiveness. Class III devices, which are often life-supporting or sustaining, undergo the most rigorous premarket approval to demonstrate their safety and efficacy before they can be marketed.

This classification applies to a wide array of devices, including those used in surgical procedures, diagnostic tools, and devices involved in patient monitoring. Thus, the system is comprehensive and encompasses all medical devices rather than being limited to just life-saving devices, surgical instruments, or those used exclusively in clinical trials.