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# FDA Updates AI/ML-Enabled Medical Device List
- URL: https://www.fdaweb.com/fda-updates-ai-ml-enabled-medical-device-list/
- Published: 2023-10-19T12:00:00.000Z
- Updated: 2026-09-14T14:13:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155605

FDA has added 171 medical devices to its list of artificial intelligence (AI) and machine learning (ML)-enabled devices legally marketed in the U.S. by 510(k) clearance, de novo request, or premarket approval. Of the new additions to the [list](https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices?utm%5Fmedium=email&utm%5Fsource=govdelivery), 155 are devices with final decision dates between 8/1/2022 and 7/30/2023, and 16 are devices from prior periods identified through a refinement of methods used to generate the list.

An agency notice [says](https://content.govdelivery.com/accounts/USFDA/bulletins/37671b1?ref=fdaweb.com) that as part of the update, FDA added insights about trends based on analyses of the data. The list includes information on AI/ML-based devices such as submission number, device and company name, and date of marketing authorization.