FDA Updates Lists of Devices that Incorporate Digital Health Technology
FDA Updates Lists of Devices that Incorporate Digital Health Technology
The U.S. Food and Drug Administration (FDA) encourages the development of innovative, safe, and effective medical/dental devices, including devices that incorporate digital health technology. The FDA has updated its searchable lists of medical/dental devices that incorporate digital health technology authorized for marketing in the United States, including:
The FDA lists are not comprehensive resources of medical/dental devices that incorporate digital health technology. Instead, they include medical/dental 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.
