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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..

The US Food and Drug Administration (FDA), Health Canada and UK MHRA (June 13) built on their 2021 guiding principles for good machine learning practice for medical device development by further identifying guiding principles for transparency for machine learning-enabled medical devices (MLMDs). As the healthcare sector continues to experience rapid proliferation of artificial intelligence (AI) ..

As artificial intelligence continues to evolve, we are seeing revolutionary opportunities to enhance health care, especially through machine learning. AI can be applied across the spectrum of health applications, including for the prevention, diagnosis, and treatment of a variety of medical conditions, as well as for a range of administrative tasks. Health products, including those that are medi..

Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together The U.S. Food and Drug Administration (FDA) issued "Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together," which outlines the agency's commitment and cross-center collaboration to protect public health while fostering responsible and ethical medical product..