Keynote 2. Strengthening FDA–WCCC Collaboration Across the Total Product Lifecycle

In the final keynote address, Rachana Visaria, PhD, Acting Director of the Division of Plastic and Reconstructive Surgery Devices within the Office of Surgical and Infection Control Devices (OHT4) at the FDA's Center for Devices and Radiological Health (CDRH), will discuss collaborative strategies to advance wound care innovation. Her keynote will address the role of real-world evidence in regulatory decision-making and highlight the FDA’s Total Product Lifecycle Advisory Program as a pathway to expedite review and market entry for breakthrough technologies with specific relevance to wound care innovation.