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  4. Public Workshop – Food and Drug Administration/National Institutes of Health Joint Workshop: Developing Implanted Brain-Computer Interface Clinical Outcome Assessments to Demonstrate Benefit, September 19 and 20, 2024 - 09/19/2024
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Workshop | In Person

Event Title
Public Workshop – Food and Drug Administration/National Institutes of Health Joint Workshop: Developing Implanted Brain-Computer Interface Clinical Outcome Assessments to Demonstrate Benefit, September 19 and 20, 2024
September 19 - 20, 2024


Date:
September 19 - 20, 2024
Day1:
- ET
Day2:
- ET

SUMMARY 

The Food and Drug Administration (FDA) and National Institutes of Health (NIH) are announcing a public workshop to engage with stakeholders in the implanted brain-computer interface device ecosystem. The purpose of the workshop is to discuss the development of clinical outcome assessments (COAs) to evaluate the effectiveness of implanted brain-computer interfaces (BCIs). The Implanted BCI devices that are focus of this workshop are neuroprostheses that interface with the central nervous system to restore lost motor and/or sensory capabilities in people with impairments in motor function and/or communication.

BACKGROUND 

Over the past few decades, researchers and device developers around the world have been investigating implanted BCIs as a means of providing communication and/or motor control for individuals with speech and physical impairments. The implanted BCIs directly access and interpret neural data from the brain and can be non-invasive, such as those that use electroencephalogram (EEG) electrodes on the scalp, or invasive that involve implanted electrodes in or near the brain. 

Being able to assess the effectiveness of new medical devices such as implanted BCIs is integral to medical device development and innovation for people living with various speech and physical impairments. Clinical outcome assessments (COAs) describe or reflect how a person feels, functions, or survives and can be reported by a health care provider, a patient, a non-clinical observer (such as a parent), or through performance of an activity or task. The COAs may be a single measure or comprised of multiple measures. 

There is a need to develop standardized COAs that can be utilized to assess the effectiveness of implanted BCIs in future clinical trials for their intended use. These COAs need to be identified and developed with generalizability and robustness to the home environment so that COAs reflect functional communication and/or motor control in real world settings.

DATE, TIME, and LOCATION

This public workshop will be held September 19, 2024, from 8:30 a.m. to 5:00 p.m. and September 20, 2024, from 8:30 a.m. to 12:00 p.m. (ET) at the following location:

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

Link for FDA Campus Information, (e.g., local airports, directions, local hotels, etc.)

http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm

WEBCAST

The public workshop will be webcasted. Register to receive the link to the webcast in a confirmation email. After the live webcast, a link for the recorded co-sponsored public workshop will be posted to the FDA webpage.

PRELIMINARY AGENDA

The following co-sponsored public workshop agenda is preliminary and subject to change. More information will be made available as presenters are confirmed. 

September 19th, 2024

Time Subject Name of Speaker/
8:30-8:45 Welcome David McMullen, MD (FDA)
John Ngai, PhD (NIH)
8:45-9:00  Emerging implanted BCI technologies state of development    
9:00-9:30 Intro to Clinical Outcome Assessments (COAs)   
9:30-10:15  The current state of COA in payor’s coverage decision making   
10:15-10:30 Break
10:30-11:15 The current state of COA in evaluating people with functional impairments  
11:15-11:30 Systematic Review of Clinical Outcome Assessments (COAs) for Communication Brain-Computer Interface Devices (cBCIs) in Amyotrophic Lateral Sclerosis (ALS) grant update  
11:30-12:30 Lunch
12:30-1:00 Patient Perspective Patient panel
1:00-1:30  Task Setting for Breakout Rooms
  • What are the gaps in COAs?
  • How should Performance Outcome Measures be used?
  • Should there be a universally applicable assessment or a toolbox of various COAs?
FDA and NIH
1:30-3:30 Breakout rooms based on indication
  • Communication (e.g., language, speech, tablet use for communication)
  • Activities of daily living (including upper limb function)
  • Mobility (e.g., ambulation with lower limb prosthesis or exoskeleton, wheelchair use)
3:30-4:30 Report back from Breakout Rooms Breakout groups to present their discussion
4:30-5:00   Closing Remarks FDA and NIH

September 20th, 2024

Time Subject Name of Speaker/
8:30-8:45  Welcome Heather Dean, PhD (FDA)
Walter Koroshetz, MD (NINDS)
8:45-9:15 From COAs to OPCs: How COAs can inform the next generation of BCI Clinical Trial Design David McMullen, MD (FDA)
9:15-9:45   From clinical trials to home: how can NIH support a sustainable eco-system for better BCI COA development and BCI adoption in treating neurological conditions NIH
9:45-10:45   Breakout rooms based on indications to revisit the previous discussions and re-evaluate responses to the prompts.
10:45-11:30    Report back from Breakout Rooms Breakout groups to present their discussion
11:30-12:00 Workshop concluding remarks and next steps FDA and NIH

REGISTRATION

If you wish to attend this public workshop, please register by 4:00 p.m. (ET) on September 12, 2024. There is no fee to register for the Workshop.  Early registration is recommended because seating is limited. Registration will be on a first-come, first-served basis.  When registering, you must provide the following information: 

Registration: https://www.surveymonkey.com/r/BCIClinicalAssessments

(1) In Person or Webcast 
(2) Name 
(3) Title 
(4) Affiliation, Company or Organization
(5) E-mail address 
(6) Telephone number
(7) Stakeholder Category (Academia, Clinician, Consultant, Government, Industry, Regulatory and Other) 

Registrants will receive confirmation when requests for participation have been accepted, if applicable. If time and space permit, onsite registration the day of the public workshop will be provided beginning at 8:00 a.m.  

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication, Information Disclosure, Training, and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, susan.monahan@fda.hhs.gov.

COMMENTS

Please submit your comments regarding the workshop to http://www.regulations.gov, Docket No. FDA-2024-N-2976 by 10/21/2024.    

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.  

Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov.  

CONTACT

For questions regarding workshop content please contact:

Mary (Molly) Keszler, MD
Medical Officer
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
10903 New Hampshire Ave.
Silver Spring, MD 20993
Email: CDRH_BCI_Workshop2024@fda.hhs.gov

 
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