#511: AI Risk Scores and Regulatory Forks: Diagnose Your Software’s Regulatory Fate
Tuesday, June 16, 2026 10:15 AM to 11:30 AM · 1 hr. 15 min. (America/New_York)
203AB
02: ClinicalTrialOps-Innovation05: PersonalizedMed-ComboProd-Diagnostics08: RegPolicy-Strategy-GlobalCollaboration
Information
Explore how FDA’s Clinical Decision Support (CDS) guidance impacts software classification in drug development. Learn to apply a decision tree through real-world case studies and a hands-on workshop to determine whether a tool is a regulated medical device or exempt CDS.
CE
ACPECMERN
Session Level
Intermediate
Featured Topics
Artificial Intelligence
Learning Objectives
Apply FDA’s CDS guidance criteria to determine whether AI software tool (used to identify patients or risk factors) qualifies as a regulated medical device or exempt CDS; Analyze real-world digital health scenarios using a structured decision tree to support regulatory classification; Evaluate the impact of software classification on drug development strategy, trial design, and regulatory planning
Speakers
MM
Michael Mayrosh
Associate Director Global Regulatory Policy and StrategyEli Lilly and Company
Jeppe Manuel
Data Science External Affairs & Intelligence DirectorNovo Nordisk A/S
Lesley Maloney
Senior DirectorEli LillyCB
Christine Baysmore
Executive Director, Regulatory Diagnostics & Digital HealthMerck Sharp & Dohme Corp.