Community Home

Flash Learn: Device or Not? Using a Decision Flowchart to Make FDA Device Determinations

DATE CHANGE: Now taking place on May 26 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.

Federal Public Policy Briefings: Understanding 21 CFR 50.54: FDA- Regulated Pediatric Research

Research involving children that poses more than minor increase over minimal risk without direct benefit requires federal review under 21 CFR 50.54/46.407, yet sponsors, investigators, and IRBs frequently hesitate to pursue this pathway. This session examines why that hesitancy persists, the regulatory challenges it creates, and how stakeholders can better navigate federal referral to advance pediatric research while maintaining participant protections.