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Advisory Committee Meeting | In Person

Event Title
November 7, 2024: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
November 7, 2024


Date:
November 7, 2024
Time:
9:00 a.m. - 6:00 p.m. 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.

Webcast Information

YouTube:
https://youtu.be/PMS5dJRtLIo

Center Date Time Location
CDRH November 7, 2024 9:00 a.m. - 6:00 p.m. Holiday Inn Gaithersburg
Two Montgomery Village Ave.
Gaithersburg, MD 20879
301-948-8900

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 

[Docket No. FDA-2024-N-4057] 

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Request for Comments--ProSense Cryoablation System

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; establishment of a public docket; request for comments.

SUMMARY:  The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the 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.  FDA is establishing a docket for public comment on this document.

DATES:  The meeting will be held on November 7, 2024, from 9 a.m. to 6 p.m. Eastern Time.

ADDRESSES:  Holiday Inn Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD 20879.  The hotel’s telephone number is 301-948-8900.  The hotel’s link can be found at:  https://www.ihg.com/holidayinn/hotels/us/en/gaithersburg/wasrv/hoteldetail.  

Answers to commonly asked questions about FDA advisory committee meetings may be accessed at:  https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FDA is establishing a docket for public comment on this meeting.  The docket number is FDA-2024-N-4057.  The docket will close on December 9, 2024.  Please note that late, untimely filed comments will not be considered.  The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 9, 2024.  Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. 

Comments received on or before October 17, 2024, will be provided to the Committee.  Comments received after that date will be taken into consideration by FDA.  In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.

You may submit comments as follows:  

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal:  https://www.regulations.gov.  Follow the instructions for submitting comments.  Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged.  Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process.  Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). 

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions):  Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions:  All submissions received must include the Docket No. FDA-2024-N-4057 for “General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.”  Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

  • Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission.  You should submit two copies total.  One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.”  FDA will review this copy, including the claimed confidential information, in its consideration of comments.  The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov.  Submit both copies to the Dockets Management Staff.  If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.”  Any information marked as “confidential” will not be disclosed except in accoaccordance with 21 CFR 10.20 and other applicable disclosure law.  For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:  https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket:  For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:  Candace Nalls, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002, 301-636-0510, Candace.Nalls@fda.hhs.gov, 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 coming to the meeting.

SUPPLEMENTARY INFORMATION:

Agenda:  On November 7, 2024, the Committee will discuss, make recommendations, and vote on clinical information related to a De Novo request for the ProSense Cryoablation System sponsored by IceCure Medical Ltd.  The discussion will focus on the sponsor’s proposed indication:  “for use in the treatment of patients with early stage, low-risk breast cancer for the treatment of breast cancer with adjuvant endocrine therapy.”

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 will be available at the location of the advisory committee meeting and at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.  Scroll down to the appropriate advisory committee meeting link.

Procedure:  Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee.  All electronic and written submissions to the Docket (see ADDRESSES) on or before October 17, 2024, will be provided to the Committee.  Oral presentations from the public will be scheduled on November 7, 2024, between approximately 1:45 p.m. and 2:45 p.m. Eastern Time.  Those individuals interested in making formal oral presentations should notify the contact person and submit 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 October 10, 2024.  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 October 15, 2024.  Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

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 Ann Marie Williams at AnnMarie.Williams@fda.hhs.gov or 301-796-5966 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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. 1001 et seq.). 

Dated:  September 6, 2024.

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).


Event Materials

Title File Type/Size Source Organization
GPSDP Nov. 7, 2024 Webcast Link pdf (134.73 KB)
GPSDP Nov. 7, 2024 Agenda pdf (165.46 KB)
GPSDP Nov. 7, 2024 Roster pdf (140.23 KB)
GPSDP Nov. 7, 2024 Panel Questions pdf (292.32 KB)
GPSDP Nov. 7, 2024 FDA Executive Summary pdf (12.72 MB)
GPSDP Nov. 7, 2024 FDA Appendix A pdf (118.30 KB)
GPSDP Nov. 7, 2024 FDA Appendix B pdf (169.54 KB)
GPSDP Nov. 7, 2024 FDA Appendix C pdf (154.72 KB)
GPSDP Nov. 7, 2024 FDA Appendix D pdf (301.68 KB)
GPSDP Nov. 7, 2024 FDA Appendix E pdf (1.01 MB)
GPSDP Nov. 7, 2024 FDA Appendix F pdf (3.69 MB)
GPSDP Nov. 7, 2024 FDA Appendix G pdf (1.29 MB)
GPSDP Nov. 7, 2024 Sponsor Executive Summary pdf (2.83 MB)
GPSDP Nov. 7, 2024 Sponsor Review Citations pdf (692.22 KB)
GPSDP Nov. 7, 2024 Sponsor Appendix H pdf (4.66 MB)
GPSDP Nov. 7, 2024 Sponsor Appendix G pdf (1.09 MB)
GPSDP Nov. 7, 2024 Sponsor Appendix F pdf (622.61 KB)
GPSDP Nov. 7, 2024 Sponsor Appendix D pdf (686.38 KB)
GPSDP Nov. 7, 2024 Sponsor Appendix C pdf (544.59 KB)
GPSDP Nov. 7, 2024 Sponsor Appendix B pdf (5.62 MB)
GPSDP Nov. 7, 2024 Sponsor Appendix A pdf (705.73 KB)
GPSDP Nov. 7, 2024 24 Hour Summary pdf (181.45 KB)
GPSDP Nov. 7, 2024 FDA Presentation pdf (3.06 MB)
GPSDP Nov. 7, 2024 Sponsor Presentation pdf (2.10 MB)
GPSDP Nov. 7, 2024 Presentation - Kenneth Tomkovich, MD pdf (66.98 KB)
GPSDP Nov. 7, 2024 Presentation - Patricia A. Ganz, MD pdf (1.92 MB)
GPSDP Nov. 7, 2024 Presentation - Monica Morrow, MD pdf (2.57 MB)
GPSDP Nov. 7, 2024 Presentation - Julie Margenthaler, MD FACS pdf (3.14 MB)
GPSDP Nov. 7, 2024 Summary Minutes pdf (522.50 KB)

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