This presentation provides an update on current priorities and initiatives at FDA CDRH to advance timely patient access to high-quality, safe, and effective medical devices. Topics include CDRH’s patient-centered vision and key programs supporting quality, innovation, and resilience across the medical device ecosystem, including Case for Quality initiatives, the Voluntary Improvement Program, the Achieving Quality Excellence Collaborative Community, ASCA, biocompatibility updates, supply chain resilience activities, PFAS-related challenges, the Quality Management System Regulation, MDSAP, and best practices for communicating effectively with FDA. The presentation emphasizes collaboration across regulators, manufacturers, healthcare providers, and other stakeholders to strengthen device quality, improve patient safety, and support responsible innovation.