AI & ML: A Review Of EMA And FDA's Approach

By Sean Hilscher and Tanvi Mehta

Considering the feverish pace of innovation in the field of AI and the inevitable impact this family of technologies has on medical product development (specifically drug development), an overview of the approaches to AI/ML regulation by leading medical product regulatory authorities, the FDA and EMA, is timely. Below we outline the documents and guidances the two regulators have released thus far, comparing and contrasting their areas of focus and concern.