Past and Current Regulations around Artificial Intelligence in SaMD

Editor's note: This is the second part of a two-part series. The first installment can be found here. The first part installment in this series examined the benefits of Artificial Intelligence/Machine Learning (AI/ML) and noted the considerations that regulatory bodies are studying for use with AI/ML algorithms. The second and final installment explores the past and current regulations, and summarizes the latest framework proposed by the U.S. Food and Drug Administration's (FDA). While current guidance around AI/ML implementation in medical devices is lacking, the FDA is working to solve the problem.