FDA Fireside Chat

This session will explore FDA perspectives on and experiences with protecting patients in neurological device research and translation, and associated neuroethics considerations.

Speakers:

• Mary Keszler, Medical Officer, FDA
• Julia Slocomb, Senior Lead Reviewer, FDA
• Francis Shen, University of Minnesota Law School (moderator)

Event

Neuroethics 2024

• Date: Thursday, April 18
• Start Time: 10:00 am / 14:00 UTC
• Duration: 30 minutes

Agenda

1. Introduction / 5 mins
2. Discussion and Q&A / 25 mins

Resources

• Organizational structure at NIH / OHT5 Office of Neurological & Physical Medicine Devices (pdf)
  
• Implantable BCI Collaborative Community

Speakers

Julia Slocomb, PhD

Senior Lead Reviewer, Acute Injury Devices Team, Division of Neuromodulation and Physical
Medicine Devices, OHT5
U.S. Food and Drug Administration

Mary Keszler, MD

Medical Officer, Acute Injury Devices Team, Division of Neuromodulation and Physical Medicine Devices, OHT5
U.S. Food and Drug Administration

Francis Shen

Francis X. Shen, JD, PhD is a Professor of Law and Faculty Member in the Graduate Program in Neuroscience at the University of Minnesota, and Chief Innovation Officer for the MGH Center for Law, Brain & Behavior.