FDA REdI Annual Conference 2019
May 29-30, 2019
The agenda is subject to change. Updated versions will be linked here as they become available. The current version is: Version 7, published on May 21, 2019.
This PDF file contains brief biographies of the FDA speakers participating in the conference.
Both of the two links above include the slides for the Keynote and Plenary.
Click here to view CDER session recordings
on SBIA YouTube Channel
Session Recordings for the CDRH (Devices) Track:
Day One:
- Keynote: Incorporating a Total Product Life Cycle Approach – William Maisel
View Recording - A Case Study on Medical Device Determination and Product Classification – Kim Piermatteo
View Recording - 510(k) Program Updates – Angela Demarco
View Recording - Appropriate Use of Voluntary Consensus Standards and the Conformity Assessment Program – Scott Colburn
View Recording - Facilitating Patient Access to Medical Devices: The Expanded Access, Early Feasibility Study, and Breakthrough Devices Programs – Maureen Dreher
View Recording - Building Quality Clinical Data into Premarket Approval Applications (PMAs) – Donna Headlee
View Recording
Day Two:
- Quality System Regulation and ISO 13485 Comparison: Corrective and Preventive Action (CAPA) Requirements – Joseph Tartal
View Recording - Corrective and Preventive Action (CAPA) Case Study – Tonya Wilbon
View Recording - Quality System: FDARA, 21st Century Cures Act, and Recent Postmarket Policy Updates – Vidya Gopal
View Recording - Medical Device Single Audit Program (MDSAP) Overview – Kenneth Chen
View Recording - FDA’s Import Requirements for Medical Devices – Terri Garvin
View Recording - Overview of the FDA Exports Program for Medical Devices – Ethny Obas
View Recording - FDA Medical Device Inspections – Maura Rooney
View Recording