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U.S. Department of Health and Human Services

Medical Devices

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Public Meeting: Strengthening the Center for Devices and Radiological Health’s 510(k) Review Process, February 18, 2010

Federal Register Notice

FDA has published a notice in the Federal Register announcing a public meeting on February 18, 2010, and requesting comments on a number of questions regarding actions that the Center for Devices and Radiological Health (CDRH) could consider taking to strengthen the premarket notification process for review of medical devices, also known as the 510(k) process.

Please see Docket No. FDA-2010-N-0054, "Strengthening the Center for Devices and Radiological Health’s 510(k) Review Process; Public Meeting; Request for Comments" and "Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Extension of Comment Period."

The original Federal Register notice, published on January 27, 2010 (Volume 75, Number 17), invited interested persons to submit comments. FDA has extended deadline for comments to March 19, 2010.

Date, Time and Location

The meeting was held on February 18, 2010, from 8:00 a.m. to 5:30 p.m. at the following location:

Hilton Washington DC North/Gaithersburg
620 Perry Pkwy.
Gaithersburg, MD 20877
301-977-8900

Additional Information

I. Planned Agenda

8:00-8:05

Welcome and Opening Remarks

Jeff Shuren, M.D., J.D., Director, CDRH

8:05-8:10

Overview : Structure of the Day and Logistics

Moderator: Mark Barnett, Associate Director for Outreach and Review, Office of Communication, Education, and Radiation Programs, CDRH

8:10-8:30

Introduction : CDRH’s Internal 510(k) Process Review and Key Challenges

Donna-Bea Tillman, Ph.D., Director, Office of Device Evaluation, CDRH

8:30-9:30

 

FDA Presentations

Presentation 1 : Issues Related to Predicate Devices

Christy Foreman, Deputy Director for Engineering and Science Review, Office of Device Evaluation, CDRH

Presentation 2 : Issues Related to New Technologies and Scientific Evidence

Arleen Pinkos, MT (ASCP), Reviewer, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH

Presentation 3 : Issues Related to Practices CDRH Has Adopted in Response to a High Volume of 510(k) Submissions

Barbara Zimmerman, Deputy Director for Premarket Program Management, Office of Device Evaluation, CDRH

Presentation 4 : Issues Related to Postmarket Surveillance and New Information about Marketed Devices

Heather Rosecrans, Director, 510(k) Staff, Office of Device Evaluation, CDRH

9:30-9:45 Break
9:45-11:45

Open Public Session 1

Registered Speakers

11:45-1:00 Lunch (on own)
1:00-1:05

Call to Order

Moderator: Mark Barnett, Associate Director for Outreach and Review, Office of Communication, Education, and Radiation Programs, CDRH

1:05-2:45

Open Public Session 2

Registered Speakers

2:45-3:00 Break
3:00-4:30

Open Public Session 3

Registered Speakers

4:30-5:30

Round-Table Discussion : Exploring the Issues

FDA Staff and Selected Participants

5:30-6:00

Open Public Session 4 : Comments from the Floor

Open to All Audience Members

6:00

Closing Remarks and Adjournment

Jeff Shuren, M.D., J.D., Director, CDRH

II. Registered Speakers

The following individuals gave scheduled presentations at the February 18 meeting, in the order listed below.

  1.  Robert Bard, Managing Director, HealthCare Technologies Consultants
  2.  Eb Bright, General Counsel and Vice President, Intellectual Property, ExploraMed
  3.  Laurie Clarke, Partner, King & Spalding, LLP
  4.  Craig Coombs, Head, Coombs Medical Device Consulting
  5.  Mark Deem, Partner, The Foundry, LLC
  6.  Daniel Dillon, Regulatory Scientist, MED Institute, Inc.
  7.  Robert Durgin, Senior Vice President, Quality, Regulatory, and Clinical Affairs, Biomet
  8.  Richard Eaton, Industry Manager, Medical Imaging & Technology Alliance
  9.  Ralph Hall, Distinguished Visiting Professor of Law, University of Minnesota
  10.  Leroy Hamilton, Private Citizen
  11.  David Tumey, Innovative Therapies, Inc.
  12.  Mark Holmes, Vice President of Regulatory and Government Affairs, CaridianBCT
  13.  Will King, Chief Executive Officer, Medical Predictive Science Corporation
  14.  Mark Leahey, President and Chief Executive Officer, Medical Device Manufacturers Association
  15.  Randall Lewis, Physician, Washington Orthopaedics & Sports Medicine
  16.  John Minier, Director, Regulatory Affairs, Small Bone Innovations
  17.  In Mun, Vice President, Research and Technology, Hospital Corporation of America, North Florida Division
  18.  Glenn Neuman, Director of Scientific Affairs, New World Regulatory Solutions
  19.  Steven Shanks, President, Erchonia Medical
  20.  John Smith, Partner, Hogan & Hartson, LLP
  21.  Robert Smith, Reviewer, Center for Devices and Radiological Health, U.S. Food and Drug Administration (Speaking as a Private Citizen)
  22.  Katie Walton, Regulatory Affairs Manager, American Medical Systems
  23.  Diana Zuckerman, President, National Research Center for Women & Families
  24.  Kelly Slone , Director of Federal Life Science Policy, National Venture Capital Association

III. Round-Table Discussion:

FDA Participants:
  • Moderator : Mark Barnett, Associate Director for Outreach and Review, Office of Communication, Education, and Radiation Programs, CDRH
  • Jeff Shuren, Director, CDRH
  • Donna-Bea Tillman, Director, Office of Device Evaluation, CDRH
  • Christy Foreman, Deputy Director for Engineering and Science Review, Office of Device Evaluation, CDRH
  • Arleen Pinkos, Reviewer, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH
  • Heather Rosecrans, Director, 510(k) Staff, Office of Device Evaluation, CDRH
  • Barbara Zimmerman, Deputy Director for Premarket Program Management, Office of Device Evaluation, CDRH
Other Participants:
  • Susan Alpert, Senior Vice President – Chief Regulatory Officer, Medtronic
  • Craig Coombs, Head, Coombs Medical Device Consulting
  • Michael Daniel, President and Founder, Daniel & Daniel Consulting
  • Mary Gross, Abbott Laboratories
  • Brian Kunst, Senior Regulatory Officer, Orthocon
  • William Maisel, Director, Medical Device Safety Institute and Assistant Professor of Medicine, Harvard Medical School
  • Ugo Joe Piasevoli, Senior Manager – Technical Engineering Department, Konica Minolta Medical Imaging
  • John Schalago, Associate Director II, Pfizer Consumer Healthcare
  • Diana Zuckerman, President, National Research Center for Women & Families

IV. Video Recording and Transcript:

A captioned video recording of the meeting is now available.

A verbatim transcript of the meeting is now available.

Presentations delivered during the meeting are also posted in the docket, and can be found at www.regulations.gov (Docket No. FDA-2010-N-0054)

Contact Us

For further information about this meeting, contact:

James Swink
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Bldg. 66, rm. 1609
Silver Spring, MD 20993
301-796-6313
e-mail: james.swink@fda.hhs.gov