FDA publishes action plan to regulate AI and machine learning based products

“On 12 January 2021, the US Food and Drug Administration (FDA) published a five part action plan which provides short-term actions to regulate products that incorporate artificial intelligence and/or machine learning (AI/ML). This ‘Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan’ was released by the Digital Health Centre of Excellence (DCE).┬áThe DCE’s aim is to further the FDA’s overarching dedication to the advancement of digital health technology.”