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:

• artificial intelligence
• augmented reality and virtual reality
• sensor-based digital health technology

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.

Questions?

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

Request for Public Comment: Identifying Accessories Suitable for Distinct Classification as Class I Devices

Today, the U.S. Food and Drug Administration (FDA) announced a “Request for Public Comment: Identifying Accessories Suitable for Distinct Classification as Class I Devices.”  The FDA is seeking information from interested parties regarding existing medical/dental device accessories that may or may not be suitable for distinct classification in Class I.  The agency considers an accessory to be a finished device that is intended to support, supplement, and/or augment the performance of another device (also known as a “parent device”), or as part of a device system.  This request for public comment is a preliminary step to help the FDA identify suitable accessories for distinct classification into Class I and is intended to seek early feedback from groups and individuals outside the Agency.  The FDA intends to consider all relevant comments submitted within 60 days, on or before February 3, 2026, to develop a proposal for the distinct classification action.