FDA REdI Annual Conference
August 25, 26, 27 & 28, 2020
The agenda is subject to change. Updated versions will be linked here as they become available. The current version is Version 9, updated on August 25.
This PDF file contains brief biographies of the FDA speakers participating in the conference.
CDER (Drugs) session recordings will be added to the SBIA YouTube Channel once they have been processed.
The CDRH (Devices) session recordings will be linked below once they have been processed.
- Plenary – John Concato and Soma Kalb
- Getting Started: CDRH Resources for You – Donna Headlee
- Benefit-Risk Throughout the Medical Device Lifecycle: Premarket, Postmarket, and Compliance – Kimberly Brown Smith
- 510k Device Modifications: Case Study – Melissa Hall
- A New Way to 510k: The Safety and Performance Based Pathway – Jason Ryans
- De Novo Classification: An Alternative Pathway to Market for New Device Types – Sergio de del Castillo
- Considering Cybersecurity in Device Development and Factors Influencing Successful Premarket Review – Lisa Simone
- Design Controls: Case Study – Joseph Tartal
- Production and Process Controls: Case Study – Vidya Gopal
- Case for Quality – Francisco Vicenty
- Medical Device Single Audit Program (MDSAP) – Kenneth Chen
- Risk Management Within A Quality System – Tonya Wilbon
- eMDR System Overview and Submission Walkthrough – Evan Jacobs
- FDA Medical Device Inspections – Laureen Genuisz
If you have questions regarding the content of the event or other CDER-specific information, please: