FDA’s White Paper on Regulation of Artificial Intelligence Examined by Akin Gump Authors in New Article

The Journal of Robotics, Artificial Intelligence & Law has published the article “FDA’s AI White Paper: To Be or Not to Be, That Is the Question,” in which Akin Gump health partners Nathan Brown and Howard Sklamberg, counsel Christin Carey and associate Marlee Gallant discuss a Food and Drug Administration white paper that proposes “a framework for regulating artificial intelligence/machine learning (“AI/ML”)-based software as a medical device (“SaMD”).

The authors write that the white paper, which was published in April, “highlights the challenges that AI/ML-based software poses to the traditional medical device regulatory framework.” They note, as the FDA has already acknowledged, “AI products with algorithms that continually adapt based on new data are not well suited to the current regulatory paradigm.”

The article outlines three broad categories of modifications to an AI/ML-based SaMD that are highlighted in the white paper, including performance, inputs and intended use. It also describes how the white paper considers AI/ML in the context of changes to an already cleared or approved SaMD. It concludes by suggesting that, despite the “conceptual status” of the white paper, “developers of SaMD with AL/ML should consider proposing some of the concepts articulated in [it].”

To read the article in its entirety, please click here.