FDA Launches List of Artificial Intelligence and Machine Learning-enabled Devices

Today, the U.S. Food and Drug Administration (FDA) is sharing a list of artificial intelligence and machine learning (AI/ML)-enabled devices legally marketed in the U.S (via 510(k) clearance, granted De Novo request, or approved PMA). The Digital Health Center of Excellence developed this new list to increase transparency and access to information on AI/ML-based medical devices. 

Although not a comprehensive list, the information provided by the FDA seeks to increase transparency about these devices and the FDA’s work in artificial intelligence and machine learning-enabled devices.

The list includes publicly available key 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)

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About the 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, email digitalhealth@fda.hhs.gov.