Because No One is Immune to the Law
December 16, 2021 - AI + Robotics, Medical Devices + Diagnostics, Digital Health, Regulatory


Patenting Artificial Intelligence in the U.S. – Considerations for AI Companies

FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a regulatory framework.  In 2021, FDA published the AI and Machine Learning Software as a Medical Device Action Plan, which outlines FDA’s approach to regulating AI/ML technologies and next steps in furthering oversight, as well as the Good Machine Learning Practice for Medical Device Development: Guiding Principles, to inform the development of Good Machine Learning Practice.  FDA also released a database of AI/ML-enabled medical devices currently marketed in the United States and will update this list as FDA reviews and authorizes additional AI/ML-enabled medical devices going forward. 

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