FDA Updates Lists of Medical Devices that Incorporate Digital Health Technology

The US Food and Drug Administration (FDA) maintains publically available lists of safe and effective medical devices, including devices that incorporate digital health technology. The Agency has recently updated its searchable lists of such devices, including

• Artificial intelligence (AI)
• Augmented reality and virtual reality
• Sensor-based digital health technology

The FDA lists are not comprehensive resources of medical devices that incorporate digital health technology. Instead, they include medical devices that have been identified primarily based on information provided in the summary descriptions of their marketing authorization documents.

Any questions related to these lists shold be direct to digitalhealth@fda.hhs.gov.