Date: 28 November 2023
Time: 17:00 - 18:00 PM CEST | 11:00 AM - 12:00 PM EST | 8:00 - 9:00 AM PST
Join us for an informative webinar where we delve into the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) Innovation Initiatives and their profound impact on medical device innovators. This webinar is designed to provide a comprehensive understanding of the multifaceted support provided by CDRH Innovation and how it can facilitate the development and market entry of cutting-edge medical devices.
- CDRH's Commitment to Innovation: Gain insights into CDRH's dedication to advancing medical technology and ensuring that patients have access to safe and innovative medical devices.
- Early Regulatory Assistance and Pre-Submission Program: Explore the FDA's Q-Submission Program, offering valuable opportunities for innovators to seek early regulatory guidance and feedback on their medical device development projects.
- Breakthrough Devices Program: Learn about the Breakthrough Devices Program and how it prioritizes specific medical devices for expedited review, facilitating increased interaction with the FDA.
- Total Product Life Cycle Advisory Program (TAP): Understand how the TAP Pilot program ensures early and strategic communication between the FDA and medical device sponsors throughout a product's life cycle.
- Global Harmonization Efforts: Discover how FDA actively participates in global harmonization efforts, promoting smoother market access for medical device innovators worldwide.
- Medical Device Coverage Initiatives: Gain insights into how CDRH's Payor Communication Task Force connects device manufacturers with payors, potentially expediting patient access by shortening the time between FDA marketing authorization and coverage decisions.
- Resources for Innovators: Learn about the wealth of resources available to medical device innovators, including CDRH webinars and the CDRH Learn platform, which offer valuable educational opportunities and insights.
- Q&A Session: Engage to get answers to your specific questions about CDRH Innovation Initiatives and their applicability to medical device innovators.
Who should attend?
- CEOs, founders, and innovators from medical device start-ups and small businesses.
- Regulatory affairs professionals, product development teams, and investors interested in leveraging FDA initiatives.
Join us for a deep dive into the comprehensive support provided by CDRH Innovation and how it can empower medical device innovators to navigate FDA processes successfully, accelerate device development, and enhance market access. Don't miss this opportunity to harness the potential of FDA initiatives and access valuable resources for your medical device innovation journey.