Masterclass: Regulation of Artificial Intelligence and AI/ML Software as a Medical Device (SaMD)

What does it require to achieve regulatory approval for innovative and transformational AI/ML and AI/ML SaMD in the US? What recommendations would companies make to the FDA to help advance the regulation and adoption of learning and non-learning AI? Join us in this masterclass, convened by Orthogonal.io in partnership with UCLA Biodesign, to discuss and develop solutions to the following questions:

•  Best and worst practices for obtaining FDA regulatory approval for AI/ML SaMD? What are the crossroads between guidance documents versus company-specific 

• FDA requirements for companies to attain regulatory decisions for AI/ML?  

•  How should learning algorithms be regulated in comparison with non-learning algorithms?  If AI/ML SaMD companies were given responsibility to develop guidance documents for learning algorithms, what would be the contents of the guidance document?