AI/ML SaMD Regulation and Validation

Ongoing developments in AI/ML medical device regulation: FDA's PCCP framework, QMSR integration, risk-based validation approaches (CSA), shadow AI risks, and practical compliance guides. Recent resources include a RAPS webinar on AI validation, a build-vs-buy HIPAA liability analysis, and a generative AI HIPAA compliance guide. Model drift and prompt sensitivity remain key concerns. The IMDRF foundational SaMD framework document is a key reference.