Medical Devices
Town Hall Discussion With the Director of CDRH and Other Senior Center Management, March 10, 2011
- Date, Time and Location
- Federal Register Notice
- Supplementary Information
- Public Presenters
- Meeting Agenda
- Contact Us
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 Secunda | Advamed |
| 2. Ms. Lana Keeton | Truth in Medicine - Mesh |
| 3. Ms. Carol Vander Stoep | Hygienist/Author |
| 4. Mrs. Sarah McFarland | Consumer Medical Mesh |
| 5. Mr. Jatinder Palta | ASTRO - Radiology |
| 6. Dr. William Glaros | Doctor of Dentistry |
| 7. Mrs. Linda Pennot | Consumer Medical Mesh |
| 8. Ms. Virgina Pritchett | Patient – Dental Amalgam |
| 9. Mr. Ken Block | Consultant |
| 10. Mrs. Janet Holt | Consumer Medical Mesh |
| 11. Ms. Kathairein Magdalena | DAMS - Dental Amalgam |
| 12. Mrs. Wendy Bradley | Truth in Medicine - Mesh |
| 13. Mrs. Joleen Chambers | Consumer – Joint Implants |
| 14. Dr. Allen Sprinkle | AIOMT – Dental Amalgam |
| 15. Ms. Melissa Mitchell Enick | DAMS - Dental Amalgam |
| 16. Mr. Donald Kerns | Diagnostic Sonography |
| 17. Mr. Kelly Gallagher | Health Advocate - Mesh |
| 18. Mr. Randy Staudt | DAMS – Dental Amalgam |
| 19. Dr. Daniel Strader | DAMS – 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
