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The FDA encourages the development of innovative, safe, and effective medical devices, including devices that incorporate Artificial Intelligence and Machine Learning (AI/ML).
The AI/ML-Enabled Medical Device List is a resource intended to identify AI/ML-enabled medical devices that are authorized for marketing in the United States (updated).
Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices | FDA
Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical D
The FDA has updated the list of AI/ML-enabled medical devices marketed in the United States as a resource to the public.
www.fda.gov
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