What distinguishes a Class II device from a Class I device?

A Class II medical device is distinguished from a Class I device primarily by the requirements it must meet, which include both general and special controls. General controls are the baseline regulatory requirements applicable to all devices, ensuring safety and effectiveness. These controls encompass aspects such as manufacturing practices, labeling, and adverse event reporting.

However, Class II devices present a higher risk than Class I devices, which is why they also require special controls. Special controls might include additional measures such as special labeling requirements, mandatory performance testing, or post-market surveillance. These additional controls help to mitigate risks associated with the device's use.

In contrast, Class I devices typically only require adherence to general controls, making them subject to a lighter regulatory burden. Because of their increased complexity or higher potential risks, Class II devices necessitate this two-tiered approach to regulation, which includes both types of controls to ensure patient safety and device efficacy.