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U.S. Department of Health and Human Services

Medical Devices

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Town Hall Discussion With the Director of CDRH and Other Senior Center Management, March 10, 2011


Date, Time and Location

The meeting was held on March 10, 2011, beginning at 8:00 a.m., at the following location:

Irving Convention Center at Las Colinas
500 West Las Colinas Blvd
Irving, Texas 75039
Phone: (972) 252-7476

The meeting was not videotaped or webcast.

Supplementary Information

Background

In 2010, CDRH held three Town Hall meetings in Minneapolis, Boston, and Los Angeles to provide the public with a new venue to discuss issues of interest with the Center. Any member of the public was invited to provide comments to or ask questions of CDRH participants. Due to the positive feedback we received for holding these meetings we plan to continue this activity in 2011 in three different locations.

The objective of this Town Hall meeting is to engage in a dialogue about issues that are of importance to the public.

Transcripts

Transcripts may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public meeting at a cost of 10 cents per page.

A transcript of the public meeting is also available online.

Public Presenters

1. Mr. Jeff SecundaAdvamed
2. Ms. Lana KeetonTruth in Medicine - Mesh
3. Ms. Carol Vander StoepHygienist/Author
4. Mrs. Sarah McFarlandConsumer Medical Mesh
5. Mr. Jatinder PaltaASTRO - Radiology
6. Dr. William GlarosDoctor of Dentistry
7. Mrs. Linda PennotConsumer Medical Mesh
8. Ms. Virgina PritchettPatient – Dental Amalgam
9. Mr. Ken BlockConsultant
10. Mrs. Janet HoltConsumer Medical Mesh
11. Ms. Kathairein MagdalenaDAMS - Dental Amalgam
12. Mrs. Wendy BradleyTruth in Medicine - Mesh
13. Mrs. Joleen ChambersConsumer – Joint Implants
14. Dr. Allen SprinkleAIOMT – Dental Amalgam
15. Ms. Melissa Mitchell EnickDAMS - Dental Amalgam
16. Mr. Donald KernsDiagnostic Sonography
17. Mr. Kelly GallagherHealth Advocate - Mesh
18. Mr. Randy StaudtDAMS – Dental Amalgam
19. Dr. Daniel StraderDAMS – Dental Amalgam

Meeting Agenda

8:00 a.m.Opening Remarks/Welcome:
Dr. Jeff Shuren, Director, CDRH, FDA
8:15 a.m.Public Presentations
10:15 a.m.Break
10:30 a.m.Question & Answer Session:
Dr. Jeff Shuren, Director, CDRH
Dr. Bill Maisel, Deputy Director for Science, CDRH
Ms. Christy Foreman, Office of Device Evaluation, CDRH
Dr. Alberto Gutierrez, Office of InVitro Diagnostics, CDRH
Mr. Steven Silverman, Office of Compliance, CDRH
12:00 p.m.Adjourn Public Meeting
12:15 p.m.Press Conference (in back of ballroom)

Contact Us

For further information about this meeting, contact:

Heather Howell
Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Avenue, Bldg. 66, rm. 4320
Silver Spring, MD 20993
301-796-5718
e-mail: heather.howell@fda.hhs.gov