FDA Issues List of Medical/Dental Devices Using Digital Health Technology
FDA Updates Lists of Medical/Dental 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.
