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