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Engaging with FDA: Center for Devices and Radiological Health (2023 Annual Meeting)

Presented by Dr. Jenna Osborn, Scientific Project Manager, FDA Center for Devices and Radiological Health Day 1, Session 5 - September 20th, 2023 Presentation Bookmarks 0:00 Introduction: Mission, Vision, and Values 3:33 CDRH’s Office of Science and Engineering Labs (OSEL) 5:48 Accelerating medical device innovation with regulatory science tools 6:53 Regulatory science and tools 7:32 From regulatory science to regulatory tools 9:45 Regulatory acceptance of tools 10:47 What are regulatory science tools? 11:44 Regulatory science tools and benefits to medical device innovators 12:30 The role of regulatory science tools in medical device development 13:19 Catalog of regulatory science tools 14:31 Research areas for OSEL regulatory science tools 15:30 Examples of regulatory science tools 24:34 Other resources for early-stage innovator 28:21 Summary The Catalyze program utilizes a new approach to translational research by supporting both the technical needs of an innovation and the management, commercialization, regulatory, and training requirements of the innovators developing them. Projects supported by Catalyze receive funding and advisory support through the National Heart, Lung, and Blood Institute (NHLBI), as well as project management assistance, access to technical services and expertise, and training opportunities through the Catalyze Coordinating Center. This research was funded, in part, by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions of the presenters are their own and should not be interpreted as representing the official policies, either expressed or implied, of the NIH. NHLBI Catalyze Public Site: https://nhlbicatalyze.org Other Catalyze Annual Meeting 2023 videos -    • Catalyze Annual Meeting 2023