Medical device class (MDC) is a regulatory category defined by the United States Food and Drug Administration (FDA). In the United States, the FDA has the authority to regulate medical devices before and after they reach the marketplace.
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A medical device's class determines what controls have been put in place to manage risk and assure patients, doctors and manufacturers that the device will operate safely and effectively. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.
Class I Medical Devices - devices in this class have a simple design and pose little to no potential risk of injury or illness to patients or operators. Examples of devices in this category include oxygen masks, examination gloves and tongue depressors.
Class II Medical Devices - devices in this class have a more complex design and pose minimal risk of injury or illness to patients or operators. Examples of devices in this category include wheel chairs, X-ray machines and cardiac monitors.
Class III Medical Devices - devices in this class have an intricate design and support or sustain human lives. Devices in this category are capable of posing substantial risk of injury. Examples of devices in this category include heart valves, implanted pacemakers and cerebral simulators. The FDA requires Class III devices to be designed with a balance between ease-of-access and strong cybersecurity controls.