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Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee. The...
SUPPLEMENTARY INFORMATION:
Agenda:
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On December 10, 2021, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the BrainsGate Ischemic Stroke System (ISS500) by BrainsGate Ltd. The proposed indications for use, submitted by the sponsor, as stated in the PMA, are as follows: The ISS500 is indicated to increase cerebral blood flow and reduce disability in adult patients with acute ischemic stroke with confirmed cortical involvement in the anterior circulation who are ineligible or have no access to IV-tPA and endovascular thrombectomy. Treatment is to be initiated between 8 and 24 hours from stroke onset (last known well).
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA's website at the time of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material and the link to the online teleconference meeting room will be available at
https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/neurological-devices-panel.
Select the link for the 2021 Meeting Materials. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Procedure:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 29, 2021. Oral presentations from the public will be scheduled on December 10, 2021, between approximately 1 p.m. and 2 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person (see
FOR FURTHER INFORMATION CONTACT
). The notification should include a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 18, 2021. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 19, 2021.
For press inquiries, please contact the Office of Media Affairs at
fdaoma@fda.hhs.gov
or 301-796-4540.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Artair Mallett at
Artair.Mallett@fda.hhs.gov
or 301-796-9638 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings
for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Dated: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.