FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

FDA has regulated medical software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances. This happens because FDA approves the final, validated version of the software. The point of AI/ML is to learn and update following deployment to improve performance. Thus the field version of the software is no longer the validated approved version. We will discuss the current regulatory requirements, how they don’t control AI/ML adequately, and approaches FDA is considering for regulation in the near future. Your development program should conform to these concepts now because, with some modifications, they will probably become regulations. Following discussion of possible future regulation, we will discuss, based on recently approved De Novo applications, how to get your AI/ML program approved now. Necessary submission documentation will be explained. This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML.