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Advisory Committee Meeting | Virtual

Event Title
UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: August 13, 2025 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
August 13, 2025

Date:
August 13, 2025
Time:
9:00 a.m. - 3:30 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://youtube.com/live/uaLvEUZkico

CenterDateTimeLocation
CDRHAugust 13, 20259:00 a.m. - 3:30 p.m.All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform.

SUMMARY:  

On August 13, 2025, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Committee) will discuss a new indication for use for dermal filler devices in the décolletage area and will make recommendations regarding risks associated with new indications for use such as in the décolletage area, the potential impact of filler material on imaging studies and clinical exams (e.g., breast cancer screening), pre-market and post-market study assessments for benefit and risk, removal of dermal filler implant material, and patient preference.

The FDA intends to make background material available to the public no later than 2 business days before the meeting. If the FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on the FDA's website at the time of the advisory committee meeting, and the background material will be posted on the FDA's website after the meeting.

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 on or before July 23, 2025, will be provided to the Committee. Oral presentations from the public will be scheduled on August 13, 2025, between approximately 11:30 a.m. and 12:30 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person identified in the Federal Register Notice 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 July 14, 2025.

DATES:  

The meeting will be held on August 13, 2025, from 9 a.m. to 3:30 p.m. Eastern Time.

ADDRESSES:  

Please note that all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.

PUBLIC COMMENT:

The FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2025-N-1731. The docket will close on September 13, 2025. 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 September 13, 2025. 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 July 23, 2025, will be provided to the Committee. Comments received after that date will be taken into consideration by the FDA. In the event the meeting is cancelled, the FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.

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 August 13, 2025 - Webcast Link pdf (185.86 KB)
GPSDP August 13, 2025 - Roster pdf (133.47 KB)
GPSDP August 13, 2025 - Panel Questions pdf (203.41 KB)
GPSDP August 13, 2025 - Executive Summary pdf (614.66 KB)
GPSDP August 13, 2025 - Agenda pdf (271.49 KB)
GPSDP August 13, 2025 - 24-Hour Summary pdf (162.07 KB)
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