What FDA’s New Machine Learning Guiding Principles Really Mean

Machine Learning has been an ongoing focus of FDA activity for some time. The first Industry Discussion Paper on the topic was launched back in 2019, followed by an Action Plan in 2021 aimed at offering guidance on the topic.

Off the back of these developments, FDA recently published a set of 10 guiding principles to inform the development of Good Machine Learning Practice (GMLP) in collaboration with Health Canada and the UK Medicines and Healthcare products Regulatory Agency.