REdI Annual Conference 2024: CDRH (Devices) Innovation in Medical Product Development (Day 1 of 2)

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities.

0:00 – Welcome to REdI 2024 Device Track, Part 1 (audio-issues) – Kim Piermatteo, MHS
2:00 – Welcome to REdI 2024 Device Track, Part 1 (audio-fixed)-Kim Piermatteo, MHS
7:58 – Introduction of Kendra Holter, MSN, RN
9:25 – Foundations of Medical Device Regulation in a World of Change – Kendra Holter, MSN, RN
48:57 – Introduction of Edward Margerrison, PhD
50:24 Accelerating Medical Device Innovation with Regulatory Science Tools - Edward Margerrison, PhD
2:43:29 – Welcome Back from Lunch
2:44:02 - Introduction of Simon Choi, MPH, PhD
2:45:17 - Recognized Consensus Standards: The Ultimate Weapon to Streamline Conformity Assessment and Advance Innovation – Simon Choi, MPH, PhD
3:21:08 Introduction of Christina Savisaar, PhD
3:22:45 Regulation of Medical Device Clinical Trials and Innovation in Clinical Evidence Generation – Christina Savisaar, PhD
4:24:15 Introduction of Kathryn J De Laurentis, PhD
4:25:48 The 510(k) Program: Overview and Updates – Kathryn J De Laurentis, PhD
5:01:19 Introduction of Hina Pinto
5:02:30 Advancing Innovation in Healthcare with Combination Products – Hina Pinto
5:40:07 Day One Closing

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