 
Today, the U.S. Food and Drug Administration (FDA) is adding 171 devices to the list of artificial intelligence and machine learning (AI/ML)-enabled devices legally marketed in the United States by 510(k) clearance, granted De Novo request, or premarket approval.
With this update, the FDA also added insights about trends based on analyses of the data. 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. The FDA maintains this list to increase transparency about AI/ML-enabled devices in this rapidly progressing field.
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 premarket 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, email digitalhealth@fda.hhs.gov.
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