When developing your technical and regulatory strategies for combination products, a key element is building the appropriate level of content and analysis from a Human Factors perspective.  If this content is inappropriately scoped, submission timelines could be significantly impacted, potentially triggering substantial additional technical activities, meetings and review cycles.  FDA Draft Guidance “Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products” (July 2024) is intended to clarify how URRA and related content can ensure the scope of Human Factors (HF) work is appropriately scoped.  In this session, FDA and industry will discuss case studies and key strategies to ensure technical and regulatory success.