FDA Regulatory Education for Industry (REdI) Annual Conference 2023 – Devices Day 2/Biologics Day 1

The devices track will provide an overview and highlights of how to get a new medical device to market. It will also discuss some best practices for ensuring that medical devices maintain their quality and continue to be safe and effective once on the market; and offer technical topic updates on biocompatibility, artificial intelligence, and radiological health.

Chapters

0:00 - Welcome and Preshow

4:07 - CDRH Day Two Welcome & Overview
- Joseph Tartal

18:33 - Addressing Regulatory Science Gaps in Artificial Intelligence (AI) and Machine Learning (ML) - Alexej Gossman

58:33 - Radiation-Emitting Products and Medical Devices Update - Laurel Burke

1:59:57 - CDRH Medical Device Import Overview - Yvette Montes

2:39:30 - All About the Form FDA Form 483 and ORA Electronic Reading Room - William Chang

3:21:46 - Closing for CDRH Sessions - Joseph Tartal

4:33:37 - CBER Sessions Welcome - Larissa Lapteva

4:47:00 - PDUFA VII Enhancements- Interactions with Office of Therapeutic Products (OTP) - Mara Miller

5:38:14 - Overview of Pediatric Research Equity Act (PREA) and Rare Pediatric Disease PRVs - Adrienne Hornatko-Munoz

6:56:36 - Preclinical Development for Cellular and Gene Therapy Products - Ernesto Moreira

7:15:41 - Preclinical Considerations for the Development of Cellular and Gene Therapy Products for IND Submissions - Gregory Conway

7:34:07 - Clinical Readiness for IND Submissions - Shelby Elenburg

8:04:20 - Questions & Answers - Ernesto Moreira, Gregory Conway, Shelby Elenburg

8:23:55 - CBER Day One Closing Remarks - Larissa Lapteva