New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning - Food, Drugs, Healthcare, Life Sciences - United States

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The long-awaited draft guidance on Clinical Decision Support (CDS) software sets forth FDA's proposed approach to regulating CDS, including software that incorporates machine learning (ML) technology. Companies developing ML software for life science applications should consider reviewing FDA's planned approach to inform their regulatory strategies. In a long-awaited move, FDA published a draft guidance on CDS software. With the rise of artificial intelligence (AI) and machine learning (ML), CDS presents a novel opportunity to analyze immensely large amounts of data for patterns or other information that may be relevant to a particular patient's diagnosis.