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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, June 22, 2010

This was the second of three CDRH Town Hall Meetings held in 2010. Other locations included:

- Bloomington, Minnesota: May 18, 2010
- Los Angeles, California: October 7, 2010



Date, Time and Location

This meeting was held on June 22, 2010 at 8:00 a.m., at the following location:

Hilton Boston/Woburn
Two Forbes Road
Woburn, MA 01801
Phone: 781-932-0999

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://www.fda.gov/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 was 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 were 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.

The transcript may also be viewed 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. Markham Luke, 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

Speaker List

  1. Ms. Pam Weagraff, Quintiles, Representing Mass Medic
  2. Mr. Richard Eaton, MITA
  3. Ms. Maha Sallam, VuEssence, Inc.
  4. Mr. Zvi Ladin, Boston MedTech Advisors
  5. Mr. William Christianson, DePuy Spine
  6. Mr. Peter Steiger, Optasia Medical
  7. Mr. Mathew Price, Centurion Medical Products
  8. Mr. Gerald Brecher, EndoEvolution, LLC
  9. Mr. Barry Sands, RQMIS, Inc (consultant)
  10. Mr. Chas Burr, Regis College
  11. Mr. Konstantin Goranov, Salutaris
  12. Mr. Eric Bornstein, Nomir Medical Technologies
  13. Mr. Eric Ankerud, Incept LLC
  14. Mr. Paul LaViolette, SV Life Sciences
  15. Mr. Dan Goldsmith, X-Laser USA
  16. Ms. Randel Richner, Neocure Group
  17. Mr. Arthur Rankis, AA Rankis & Associates, Inc.
  18. Mr. Joel Weinstein, BioSphere Medical Inc.
  19. Mr. Nathaniel Sims, Massachusetts General Hospital
  20. Mr. Jeff Secunda, AdvaMed
  21. Ms. Sheila Hemeon-Heyer, Boston Scientific Corp.

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