This interactive Flash Learn introduces a practical decision flowchart designed to assist research and compliance professionals in determining whether a product meets the definition of a medical device—with special emphasis on software as a device. The session provides hands-on guidance for navigating device determinations in a structured and consistent manner.
Experienced professionals involved in FDA-regulated research will share real-world examples and highlight common areas where institutions get stuck—particularly when evaluating AI-enabled tools and software products. Participants will apply the decision chart to sample scenarios and practice identifying intended use, relevant guidance, and potential regulatory pathways.