RAIL Publishes Akin Gump Article on FDA Plan for AI/ML Learning-Enabled Software as a Medical Device

Journal of Robotics, Artificial Intelligence & Law has published the article 'FDA Releases Action Plan for Artificial Intelligence/Machine Learning-Enabled Software as a Medical Device,' co-authored by Akin Gump health care and life sciences partner Nathan Brown and associate Emily Gerry.

The article, first published as an Akin Gump client alert, discusses the Food and Drug Administration's (FDA) approach to artificial intelligence and machine learning (AI/ML). It notes that the FDA has published an Action Plan that builds on and addresses stakeholder feedback from a proposed AI/ML regulatory framework published in 2019. The plan, the authors write, 'sets in motion a series of concrete steps to build the fundamental regulatory structure for this technology.'

Looking ahead, the authors write that the FDA 'remains interested in feedback as it works to implement the Action Plan and will continue to engage with industry stakeholders and agency actors in a harmonious approach.'

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