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# Workshop Advances Brain/Computer Interface Assessment
- URL: https://www.fdaweb.com/workshop-advances-brain-computer-interface-assessment/
- Published: 2024-10-08T12:00:00.000Z
- Updated: 2026-09-14T14:43:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157940

A 9/19-9/20 workshop sponsored by FDA and the National Institutes of Health on “Developing Implanted Brain/Computer Interface Clinical Outcome Assessments to Demonstrate Benefit” was intended to help resolve some of the hurdles that exist in commercializing that device ecosystem for brain/computer interfaces (BCI) that may soon one day exist. That’s the hope expressed by FDA Office of Neurological and Physical Medicine Devices director **David McMullen** in welcoming remarks on behalf of the agency as shown in a workshop [transcript](https://downloads.regulations.gov/FDA-2024-N-2976-0005/attachment%5F1.pdf?ref=fdaweb.com).

“FDA is actively involved in working collaboratively to overcome these hurdles through a variety of stakeholder engagements from conferences, guidance development, listening sessions, and recently participation in the implanted brain/computer interface collaborative community,” he said. “This workshop continues these efforts with a focus on developing clinical outcome assessments to enable regulators and all stakeholders, including patients, providers, and payers the ability to assess both benefit and risk to make informed decisions.”

McMullen said the agency hoped the workshop would continue to develop the evolution of BCI clinical outcome assessments that can demonstrate a functional benefit to patients.

The workshop included stakeholder talks from patients, clinical researchers, outcome development experts, funders, and regulators, and breakout sessions where participants were asked to discuss helping to develop the next generation of clinical outcome assessments to drive forward the development of BCIs.

Reports on the talks and discussions are included in the agency transcript.