As the importance of AI and diagnostics continues to grow, medical devices become more complex, and FDA policies evolve, regulatory missteps can create late surprises and require costly fixes. This workshop provides a practical regulatory playbook addressing key FDA developments, common questions, and potential pitfalls to help keep teams aligned and timelines intact.

Topics of discussion include:

• The impact of FDA’s transition to a risk-based quality management system regulation (QMSR) across device regulatory pathways, as well as what this means for international harmonization
• Cybersecurity and implementing statutory requirements for “cyber devices”
• Classifying products as SaMD versus clinical decision support (CDS) or general wellness products under FDA’s revised guidance
• PCCPs for AI-enabled devices
• Developing companion diagnostics, including considerations for coordination with therapeutic product development
• Strategies for engaging with a changing FDA on various issues, including combination products