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
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