What are the classifications for medical devices based on their level of risk?

The classification of medical devices into Class I, Class II, and Class III is a fundamental aspect of regulatory oversight by the FDA, reflecting the level of risk associated with their use.

Class I devices are categorized as low risk. They typically do not require premarket approval, though they must adhere to general controls to ensure safety and effectiveness. Examples include elastic bandages and examination gloves.

Class II devices are considered to be of moderate risk. These devices generally require greater regulatory control than Class I devices and may need to demonstrate compliance with specific performance standards or undergo a premarket notification process (510(k)). Examples include infusion pumps and some diagnostic imaging devices.

Class III devices represent high risk. These are typically life-sustaining or life-supporting products where safety and effectiveness must be demonstrated through extensive premarket approval (PMA) processes. Examples include pacemakers and certain implantable devices.

This classification system ensures that devices are appropriate for their intended use and helps protect public health by intensifying regulatory scrutiny based on their risk level.