NYSDA Publications

FDA Updates List of Approved AI and ML Medical/Dental Devices

Per the notice below, the United States Food and Drug Administration (FDA) has updated its list of approved artificial intelligence (AI) and machine learning (ML) medical/dental devices.

FDA Updates List of Artificial Intelligence and Machine Learning-Enabled Devices

FDA is adding 178 devices to the list of artificial intelligence and machine learning (AI/ML)-enabled devices legally marketed in the U.S. by 510(k) clearance, granted De Novo request, or approved PMA.  The Center for Devices and Radiological Health’s (CDRH) Digital Health Center of Excellence first posted this list in 2021.  With this update, the FDA has also added the ability to download the list as an Excel file.  This list is not meant to be an exhaustive or comprehensive resource of AI/ML-enabled medical devices.  Rather, it is a list of AI/ML-enabled devices across medical disciplines, based on publicly available information.  With this update, the FDA seeks to increase transparency about AI/ML-enabled devices.  The updated list includes information on AI/ML-based devices such as:

  • Submission number
  • Device and company name
  • Date of marketing authorization of the device [510(k) clearance, granting of De Novo, or PMA approval]

About the CDRH Digital Health Center of Excellence

Launched in September 2020 and located in the FDA’s Center for Devices and Radiological Health (CDRH), the Digital Health Center of Excellence is committed to strategically advance science and evidence for digital health technologies within the framework of the FDA’s regulatory and oversight role.  The goal of the Digital Health Center of Excellence is to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.

Questions?

If you have questions about the Digital Health Center of Excellence, e-mail: digitalhealth@fda.hhs.gov.
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