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  4. December 10, 2021: Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 12/10/2021
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Advisory Committee Meeting | Virtual

Event Title
December 10, 2021: Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
December 10, 2021

Date:
December 10, 2021
Time:
9:00 AM - 6:00 PM ET

What is an advisory committee?

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.

Center Date Time Location
CDRH December 10, 2021 9:00 a.m. - 6:00 p.m. Please note that due to the impact of
this COVID-19 pandemic, all meeting
participants will be joining this advisory
committee meeting via an online
teleconferencing platform.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 

[Docket No. FDA-2021-N-0008]

Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  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 general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.  The meeting will be open to the public.

DATES:  The meeting will take place virtually on December 10, 2021, from 9 a.m. to 6 p.m. Eastern Time. 

ADDRESSES:  Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.  Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at:  
https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings.

FOR FURTHER INFORMATION CONTACT:  James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002, James.Swink@fda.hhs.gov, 301-796-6313, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area).  A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.  Therefore, you should always check the Agency’s website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting.

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.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. 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 the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at 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).

 
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