Medical Devices

Public Workshop - Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop, November 19-20, 2015

The Food and Drug Administration (FDA) is announcing the following two-day public workshop entitled, “Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop.” The focus of the first day of the workshop was cognitive assessment medical devices, which are intended to provide healthcare professionals with an evaluation of cognitive function through non-invasive measurements. The focus of the second day of the workshop was non-invasive brain stimulation medical devices, which are medical devices that are intended to improve, affect, or otherwise modify the cognitive function of a normal individual (i.e., without a treatment objective) by means of non-invasive electrical or electromagnetic stimulation to the head. The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with medical devices for assessing and influencing cognitive function.


Date, Time and Location

This 2-day workshop was held November 19-20, 2015, beginning at 8:30 a.m. – 5:00 p.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

The meeting was webcast.

Agenda

Day One: November 19, 2015

TimeMeeting TopicPresenter
8:30-8:40AMIntroduction to FDA's Public Workshop-Day 1William H. Maisel (FDA, ODE)
8:40-9:40AMFDA Overview of Neurodiagnostic Medical DevicesJay Gupta (FDA, ODE)
Deborah Wolf (FDA, OC)
9:40-9:55AMBreak 
9:55-10:40AMState of the Science PresentationsPresenters:
Alison Cernich (NIH, NICHD)
Philip Harvey (University of Miami) via webcast
10:40-11:40AMStakeholder Perspectives on Benefits and Risks PanelPanelists:
Sarah Lisanby (NIH, NIMH)
Col. Dallas Hack (US Army, Retired)
Keith Fargo (Alzheimer's Association)
Stacy Haller (BrightFocus Foundation)
11:40-12:15AMPanel Q&A 
12:15-12:30PMIntroduction to Breakout Sessions 
12:30-1:30PMLunch (on your own) 

1:30-2:30PM

Concurrent Breakout Sessions
Benefit and Risk Considerations
(Salon A)
Session Moderators
Jay Gupta (FDA, ODE)
Lakshmi Vishnuvajjala (FDA, OSB)
Murali Doraiswamy (Duke University)
Scientific and Clinical Evidence
(Room 1406)
Tim Marjenin (FDA, ODE)
Amber Story (NSF)
Tresa Roebuck-Spencer
(National Academy of Neuropsychology)
Clinical Trial Design Considerations
(Salon B)
Peter Como (FDA, ODE)
Bipasa Biswas (FDA, OSB)
Col. Dallas Hack (US Army, Retired)
2:30-2:40PMBreak 
2:40-3:40PMConcurrent Breakout Sessions
Benefit and Risk Considerations
(Salon A)
Session Moderators
Jay Gupta (FDA, ODE)
Lakshmi Vishnuvajjala (FDA, OSB)
Murali Doraiswamy (Duke University)
Scientific and Clinical Evidence
(Room 1406)
Tim Marjenin (FDA, ODE)
Amber Story (NSF)
Tresa Roebuck-Spencer
(National Academy of Neuropsychology)
Clinical Trial Design Considerations
(Salon B)
Peter Como (FDA, ODE)
Bipasa Biswas (FDA, OSB)
Col. Dallas Hack (US Army, Retired)
3:40-4:00PMBreak 
4:00-4:30PMBreakout Session Summaries 
4:30-4:45PMMeeting Summary and Next Steps 

Day Two: November 20, 2015

TimeMeeting TopicSpeaker
8:30-8:40AMIntroduction to FDA's Public Workshop-Day 2Carlos Peña (FDA, ODE)
8:40-9:40AMFDA Overview of Non-Invasive Neurostimulation Devices & Cognitive FunctionTim Marjenin (FDA, ODE)
Leonardo Angelone (FDA, OSEL)
9:40-9:55AMBreak 
9:55-10:55AMState of the Science PresentationsPresenters:
Alvaro Pascual-Leone (Harvard University) via webcast
Sarah Lisanby (NIH, NIMH)
Eric Wassermann (NIH, NINDS)
10:55-11:00AMIntroduction to the Government Agencies PanelRobbie Barbero (Office of Science and Technology Policy)
11:00-11:45PMGovernment Agencies PanelPanelists:
Robbin Miranda (DARPA)
Alexis Jeannotte (IARPA)
Treye Thomas (CPSC)
Michelle Rusk (FTC)
Tim Marjenin (FDA)
Jim Deshler (NSF)
11:45-12:00PMPanel Q&A 
12:00-1:00PMLunch (on your own) 
1:00-2:00PMStakeholder Perspectives on Benefits and Risks PanelPanelists
Anna Wexler (Massachusetts Institute of Technology)
Hank Greely (Stanford University)
Nita Farahany (Duke University)
John Reppas (Neurotechnology Industry Organization)
Diane Dorman (Consumer Representative)
2:00-2:15PMPanel Q&A 
2:15-2:25PMIntroduction to Breakout Sessions 
2:25-3:25PMConcurrent Breakout Sessions
Regulatory Assessment and Benefit and Risk Considerations
(Salon A)
Session Moderators
Tim Marjenin (FDA, ODE)
John Reppas (Neurotechnology Industry Organization)
 Ethical Considerations
(Salon B)
Jay Gupta (FDA, ODE)
Hank Greely (Standford University)
Nita Farahany (Duke University)
Jim Giordano (Georgetown University Medical Center)
 Clinical Trial Design Considerations
(Salon C)
Peter Como (FDA, ODE)
Scott Aaronson (Sheppard Pratt Health System)
Mi Hillefors (NIMH)
3:25-3:30PMBreak 

3:30-4:30PM

Concurrent Breakout Sessions
Regulatory Assessment and Benefit and Risk Considerations
(Salon A)
Session Moderators
Tim Marjenin (FDA, ODE)
John Reppas (Neurotechnology Industry Organization)
Ethical Considerations
(Salon B)
Jay Gupta (FDA, ODE)
Hank Greely (Standford University)
Nita Farahany (Duke University)
Jim Giordano (Georgetown University Medical Center)
Clinical Trial Design Considerations
(Salon C)
Peter Como (FDA, ODE)
Scott Aaronson (Sheppard Pratt Health System)
Mi Hillefors (NIH, NIMH)
4:30-4:45PMBreak 
4:45-5:15PMBreakout Session Summaries 
5:15-5:30PMMeeting Summary and Next Steps 

Webcast

Archived Webcast Links:

Transcripts

Contact Us

For questions regarding workshop content please contact:

Hilda Scharen, Center for Devices and Radiological Health, Food and Drug Administration, Bldg 66, rm 3625, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6815, Hilda.Scharen@fda.hhs.gov

Jay Gupta, Neurostimulation Devices Branch, Division of Neurological and Physical Medicine Devices, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-2795, Jay.Gupta@fda.hhs.gov

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