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  4. March 25-26, 2019: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 03/25/2019 - 03/26/2019
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Advisory Committee Meeting

Event Title
March 25-26, 2019: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
March 25-26, 2019

Date:
March 25-26, 2019
Time:
08:00 AM - 06:00 PM EDT

Center Date Time Location
CDRH March 25-26, 2019 8:00 a.m. - 6:00 p.m. FDA White Oak Campus
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503
Silver Spring, MD 20993-0002

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No.  FDA-2019-N-0426]

General and Plastic Surgery 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 General and Plastic Surgery 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 be held on March 25 and 26, 2019, 8 a.m. to 6 p.m. 

ADDRESSES:  FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002.   Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:  https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm
Information about the FDA’s Meeting facility on the White Oak Campus can be found at https://www.fda.gov/aboutfda/workingatfda/buildingsandfacilities/whiteoakcampusinformation/ucm241740.htm

FOR FURTHER INFORMATION CONTACT:  Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993-0002, Patricio.Garcia@fda.hhs.gov, 301- 796-6875, 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 March 25 and 26, 2019, the committee will discuss and make recommendations regarding the benefits and risks of breast implants indicated for breast augmentation and reconstruction concerning the following topics: (1) breast implant associated anaplastic large cell lymphoma (BIA-ALCL); (2) systemic symptoms reported in patients receiving breast implants; (3) the use of registries for breast implant surveillance; (4) magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants; (5) the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy; (6) the use of real-world data and patient perspectives in regulatory decision making, and (7) best practices for informed consent discussions between patients and clinicians. 

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 at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting.  Background material is available 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.  Written submissions may be made to the contact person on or before March 4, 2019.  Oral presentations from the public will be scheduled on March 25, 2019, between approximately 11 a.m. and 12 noon and 2:30 p.m. to 3:30 p.m.  Oral presentations from the public will be scheduled on March 26, 2019, between approximately 10 a.m. and 11 a.m. and 3 p.m. to 4 p.m.  Those individuals interested in making formal oral presentations should notify the contact person and indicate in which session they would like to present (which day, morning or afternoon session).  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 February 27, 2019.  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 sessions.  The contact person will notify interested persons regarding their request to speak by February 28, 2019.

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 AnnMarie 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. app. 2).

Dated:  February 11, 2019.

Lowell J. Schiller,

Acting Associate Commissioner for Policy.
 


Meeting Materials

Title File Type/Size Source Organization
General and Plastic Surgery Devices Panel March 25-26, 2019 Meeting Information for the Public pdf (52.63 KB)
General and Plastic Surgery Devices Panel March 25, 2019 Agenda pdf (145.47 KB)
General and Plastic Surgery Devices Panel March 26, 2019 Agenda pdf (118.2 KB)
General and Plastic Surgery Devices Panel March 25-26, 2019 FDA Executive Summary pdf (847.83 KB)
General and Plastic Surgery Devices Panel March 25-26, 2019 FDA Executive Summary Appendix pdf (69.91 KB)
General and Plastic Surgery Devices Panel March 25-26, 2019 Panel Questions pdf (71.28 KB)
General and Plastic Surgery Devices Panel March 25-26, 2019 Roster pdf (50.07 KB)
General and Plastic Surgery Devices Panel March 25-26, 2019 24 Hour Summary pdf (65.33 KB)
General and Plastic Surgery Devices Panel March 25, 2019 FDA Presentation pdf (1.11 MB)
General and Plastic Surgery Devices Panel March 26, 2019 FDA Presentation pdf (977.72 KB)
General and Plastic Surgery Devices Panel March 25, 2019 Webcast pdf (41.17 KB)
General and Plastic Surgery Devices Panel March 26, 2019 Webcast pdf (40.54 KB)
General and Plastic Surgery Devices Panel March 26, 2019 Open Docket pdf (41.49 KB)
General and Plastic Surgery Devices Panel March 25-26, 2019 Mentor Briefing Package pdf (1.31 MB)
General and Plastic Surgery Devices Panel March 25-26, 2019 Sientra Briefing Package pdf (288.37 KB)
General and Plastic Surgery Devices Panel March 25, 2019 Presentation (Allergan) pdf (1.25 MB)
General and Plastic Surgery Devices Panel March 25, 2019 Presentation (Mentor) pdf (1.52 MB)
General and Plastic Surgery Devices Panel March 25, 2019 Presentation (Sientra) pdf (253.94 KB)
General and Plastic Surgery Devices Panel March 25, 2019 Presentation (Ideal) pdf (2.48 MB)
General and Plastic Surgery Devices Panel March 25, 2019 Presentation (Amanda Jones, M.Sc.) pdf (283.64 KB)
General and Plastic Surgery Devices Panel March 25, 2019 Presentation (Jamee Cook) pdf (2.03 MB)
General and Plastic Surgery Devices Panel March 25, 2019 Presentation (Andrea Pusic, MD, MHS, FACS, FRCSC) pdf (4.05 MB)
General and Plastic Surgery Devices Panel March 25, 2019 Presentation (Mark W. Clemens, MD, FACS) pdf (21.35 MB)
General and Plastic Surgery Devices Panel March 25, 2019 Presentation (Jan Cohen Tervaert ) pdf (5.42 MB)
General and Plastic Surgery Devices Panel March 25, 2019 Presentation (Diana Zuckerman, PhD) pdf (298.96 KB)
General and Plastic Surgery Devices Panel March 26, 2019 Presentation (Allergan) pdf (2.01 MB)
General and Plastic Surgery Devices Panel March 26, 2019 Presentation (Mentor) pdf (1.57 MB)
General and Plastic Surgery Devices Panel March 26, 2019 Presentation (Sientra) pdf (242.1 KB)
General and Plastic Surgery Devices Panel March 26, 2019 Presentation (Ideal) pdf (2.33 MB)
General and Plastic Surgery Devices Panel March 26, 2019 Presentation (Edwin G. Wilkins MD MS) pdf (3.37 MB)
General and Plastic Surgery Devices Panel March 26, 2019 Presentation (Stamatia V. Destounis, MD, FACR) pdf (499.84 KB)
General and Plastic Surgery Devices Panel March 26, 2019 Presentation (Jonathan M. Green, MD MBA) pdf (702.21 KB)
General and Plastic Surgery Devices Panel March 26, 2019 Presentation (Lynn Jeffers, MD, FACS) pdf (1.5 MB)
General and Plastic Surgery Devices Panel March 26, 2019 Presentation (Grant Stevens, MD) pdf (591.97 KB)
General and Plastic Surgery Devices Panel March 25, 2019 Transcript pdf (1.97 MB)
General and Plastic Surgery Devices Panel March 26, 2019 Transcript pdf (1.97 MB)

FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)

Please call the Information Line for up-to-date information on this meeting.

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 Web site and call the FDA Advisory Committee Information Line 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 Lauren Tesh at (301) 796-9001 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).