FAQ About Wearable Health Technology
How is wearable health technology regulated?
The regulation of wearable health technology varies depending on the type of device and its intended use. In the United States, wearable health technology is regulated by the Food and Drug Administration (FDA) and is classified based on its level of risk to patients.
Devices that are considered low risk and pose minimal risk to patient safety, such as fitness trackers, are not typically regulated by the FDA. However, devices that are used for medical purposes or that pose a higher risk to patient safety are subject to FDA regulation.
