Medical Devices
Town Hall Discussion With the Director of CDRH and Other Senior Center Management, October 7, 2010
This was the last of three CDRH Town Hall Meetings held in 2010. Other locations included:
- Bloomington, Minnesota: May 18, 2010
- Boston, Massachusetts: June 22, 2010
Date, Time and Location
The meeting was held on October 7, 2010 at 8:00 a.m. at the following location:
Hilton Irvine/Orange County Airport Hotel
18800 MacArthur Blvd
Irvine, CA 92612
Phone: (949) 833-9999
The meeting was not videotaped or webcast.
Supplementary Information
Background
CDRH announced four priority areas of activity for fiscal year 2010, each of which presents significant opportunities to improve the Center’s effectiveness in fulfilling our public health mission. More information, including specific goals and actions associated with each priority, is available under “CDRH Strategic Planning” at: http://wcms.fda.gov/FDAgov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/default.htm.
Public Meeting
The objective of this public meeting was to present the Center for Devices and Radiological Health (CDRH) FY 2010 Priorities. In addition, FDA is interested in engaging in discussions about issues that are of importance to the medical device industry. CDRH wishes to obtain feedback/ideas for facilitating two-way communication between CDRH and the medical device industry.
The meeting opened with an introduction of CDRH Senior Staff in attendance. Following introductions, Dr. Jeffrey Shuren, the Director of CDRH, presented the FY 2010 CDRH Priorities. Next, industry representatives and other public citizens was given the opportunity to present comments to CDRH Senior Staff. In addition, the attendees from CDRH responded to questions presented by industry and other public citizens.
Transcripts
Transcripts of the public meeting 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:
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) |
Public Presentations
- David Gallaher - California Healthcare Institute
- Richard Eaton - Medical Imaging & Technology Alliance
- Mark Deem - The Foundry
- Jack Dhuwalia - JD Consulting
- Serrah Namini - Sotera Wireless
- Roger Lewis - Harbor-UCLA Medical Center
- Thomas Chaly - The Feinstein Institute for Medical Research
- Kevin McNerney - Orange County Medical Device Network
- Janet Trunzo - Advamed
- Sybil Goldrich - Private Citizen
- Rita Redberg - UCSF Medical Center
- George Carpenter - CNBS Response, Inc.
- Anette Asher - LSIT Global Institute
- Joe Panetta - BIOCOM
- Paul Biggins - Toshiba
- Victoria Pearson - Medtronic
- Neelu Medhekar - Ethicon, Inc.
- Stephen Dolle - Dolle Communications
- Mathew Jenusaitis - Octane, Inc
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
