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Updated and New Lists of Medical Devices that Incorporate Digital Health Technologies

The U.S. Food and Drug Administration (FDA) encourages the development of innovative, safe, and effective medical devices, including devices that incorporate digital health technologies. The FDA provides searchable lists of medical devices authorized for marketing in the United States, including:

• an updated list of artificial intelligence-enabled medical devices
• an updated list of medical devices that incorporate augmented reality and virtual reality
• a new list of sensor-based digital health technology medical devices.

Digital health innovators can refer to the medical device lists to gain insights into the current device landscape and regulatory expectations, which can help foster innovation and ensure public safety. The lists also provide transparency for healthcare providers and patients to clearly identify when medical devices use digital health technologies.

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

Questions?

If you have questions about this communication, contact DigitalHealth@fda.hhs.gov.