What is used to determine the classification of a medical device under FDA regulations?

The classification of a medical device under FDA regulations is determined primarily by the intended use of the device and its associated risks to patients. This approach aligns with the FDA’s risk-based classification system, which categorizes devices into three classes based on the level of control necessary to assure the safety and effectiveness of the device.

Class I devices are considered to have low risk and are subject to the least regulatory control, whereas Class II devices have a moderate risk and require special controls to ensure safety and effectiveness. Class III devices are those that pose the highest risk and usually require premarket approval, demonstrating that they are safe and effective through clinical data.

Therefore, the classification process assesses how a device is intended to be used, including its therapeutic claims, and evaluates the potential risks associated with its use, ensuring that appropriate measures are in place to mitigate any hazards to patients. Other factors such as size, shape, manufacturing cost, or the manufacturer’s reputation do not directly influence the regulatory classification by the FDA.