What are the three main classes of medical devices defined by the FDA?

The three main classes of medical devices defined by the FDA are Class I, Class II, and Class III. This classification system is essential in determining the regulatory requirements for medical devices based on the level of risk they pose to patients and users.

Class I devices are considered to have the lowest risk and typically include items that are subject only to general controls. These controls may include device registration, good manufacturing practices, and labeling requirements. Examples include bandages and examination gloves.

Class II devices have a moderate level of risk and usually require both general and special controls to ensure safety and effectiveness. These special controls may include performance standards, postmarket surveillance, and patient registries. Examples include infusion pumps and diagnostic ultrasound devices.

Class III devices are associated with the highest risk and usually require premarket approval (PMA) to demonstrate their safety and effectiveness through clinical testing. This category includes devices that support or sustain life, are implanted, or present a potential unreasonable risk of illness or injury. Examples include pacemakers and artificial heart valves.

Understanding this classification system is crucial for regulatory affairs professionals, as it provides a framework for navigating the FDA's regulatory processes and ensuring compliance.