Software, apps, and AI tools are increasingly embedded in research—but when do they cross the line into regulated medical devices? This session provides a practical, IRB-focused overview of Software as a Medical Device (SaMD), helping attendees spot key triggers for FDA oversight and avoid common missteps. Walk away with simple heuristics to support consistent, defensible determinations—without needing to be an FDA expert.
CIP®: 0.5 continuing education credit hours