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CDRH 2008 Meeting Documents


Anesthesiology and Respiratory Therapy Devices Panel
Executive Secretary: Neel Patel (HFZ-480), 240-276-3700

December 5, 2008 (Meeting ID: 4405)

June 12, 2008

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Circulatory System Devices Panel
Executive Secretary: James Swink (HFZ-450), 240-276-4000

November 20, 2008 (Meeting ID: 2008-4393)

  • Notice of Meeting (htm) (Meeting ID: 4393)
  • Draft Agenda (pdf)
  • Roster (pdf) (Updated)
  • Briefing Information (html)
  • Questions (pdf)
  • Slides (html)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

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Clinical Chemistry and Clinical Toxicology Devices Panel
Executive Secretary: Tracy Phillips, Ph.D. (HFZ-440), 240-276-0700

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Dental Products Panel
Executive Secretary: Michael J. Ryan, (HFZ-480), 240-276-3773

 

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Device Good Manufacturing Practice Advisory Committee
Executive Secretary: Collin L. Figueroa (HFZ-342). 240-276-0228

 

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Ear, Nose, and Throat Devices Panel
Executive Secretary: James Kane, Ph.D. (HFZ-460), 240-276-4242

 

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Gastroenterology and Urology Devices Panel
Exective Secretary: Jeffrey Cooper, D.V.M. (HFZ-470), 240-276-4151

June 25, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Draft Agenda (pdf)
  • Draft Update Roster (pdf)
  • Final Roster (pdf)
  • Briefing Information (htm)
  • Questions (htm)
  • Slides (html)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

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General and Plastic Surgery Devices Panel
Exective Secretary: Lisa Lim (HFZ-410), 240-276-3555

November 18 and 19, 2008 (Meeting ID: 2008-4391)

  • Notice of Meeting (htm)
  • Waivers for Conflicts of Interests (html)
  • Draft Agenda for November 18, 2008 Meeting (pdf)
  • Draft Agenda for November 19, 2008 Meeting (pdf)
  • Panel Roster for November 18, 2008 Meeting (pdf)
  • Final Panel Roster for November 19, 2008 Meeting (pdf)
  • Briefing Information for November 18, 2008 Meeting (html)
  • Briefing Information for November 19, 2008 Meeting (html)
  • Questions for November 18, 2008 Meeting (pdf)
  • Questions for November 19, 2008 Meeting (pdf)
  • Transcript for November 18, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf)
  • Transcript for November 19, 2008 Meeting: Part1 (pdf), Part2 (pdf)

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General Hospital and Personal Use Devices Panel
Exective Secretary: Scott A. Colburn, BSN, RN, LT, USPHS (HFZ-480), 240-276-3707

 

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Device Good Manufacturing Practice Advisory Committee
Executive Secretary: Collin L. Figueroa (HFZ-342), 240-276-0228

 

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Hematology and Pathology Devices Panel
Executive Secretary: Louise Magruder (HFZ-440), 240-276-1248

July 18, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest (htm)
  • Draft Agenda (pdf)
  • Draft Panel Roster (pdf)
  • Briefing Information (html)
  • Slides (html)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf)
  • Minutes (pdf)

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Immunology Devices Panel
Executive Secretary: Dai Li, M.D., Ph.D. (HFZ-440), 240-276-0997

December 3, 2008 (Meeting ID: 2008-4403)

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Medical Devices Dispute Resolution Panel
Executive Secretary: Nancy Braier (HFZ-5), 301-827-7967

 

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Microbiology Devices Panel
Executive Secretary: Marieann Brill (HFZ-440), 240-276-0726

 

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Molecular and Clinical Genetics Panel
Executive Secretary: Karen BijWaard, MS, CLSp[MB] (HFZ-440), 240-276-0849

 

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National Mammography Quality Assurance Advisory Committee
Executive Secretary: Normica Facey (HFZ-240), 240-276-3288

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Neurological Devices Panel
Executive Secretary: Peter Hudson (HFZ-410), 240-276-3705

 

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Obstetrics and Gynecology Devices Panel
Executive Secretary: Michael T. Bailey, Ph.D., (HFZ-470), 240-276-4100

December 11, 2008 (Meeting ID: 2008-4392)

May 16, 2008 (Meeting postponed, see Notice below)

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Ophthalmic Devices Panel
Executive Secretary: Karen Warburton (HFZ-460), 240-276-4238

June 10, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest (html)
  • Final Agenda for June 10, 2008 Meeting (pdf)
  • Draft Agenda (pdf)
  • Draft Roster (pdf)
  • Briefing Information (html)
  • Draft Questions (htm)
  • Written Comments (html)
  • Slides (html)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Minutes (pdf)

April 25, 2008 (April 24, 2008 Meeting day CANCELLED)

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest for April 24 & 25, 2008 Meeting (html)
  • Draft Agenda for April 25, 2008 Meeting (pdf)
  • Draft Roster for April 25, 2008 Meeting (pdf)
  • Briefing for April 25, 2008 Meeting (html)
  • Draft Questions for April 25, 2008 Meeting (pdf)
  • Slides (html)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Written Comments (html)
  • Minutes (pdf) (htm)

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Orthopaedic and Rehabilitation Devices Panel
Executive Secretary: Ronald Jean, Ph.D. (HFZ-410), 240-276-3676

December 9, 2008 (Meeting ID: 2008-4404)

November 14, 2008

  • Notice of Meeting (html)
  • Waivers for Conflicts of Interests (html)
  • Draft Agenda (pdf)
  • Draft Roster (pdf)
  • Briefing Information (html)
  • Draft Questions (pdf)
  • Slides (html)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf)

July 15, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • No Waivers for Conflicts of Interests
  • Agenda (pdf)
  • Panel Roster (pdf)
  • Briefing Information (html)
  • Draft Questions (pdf)
  • Slides (html)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

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Radiological Devices Panel
Executive Secretary: Nancy Wersto, (HFZ-470), 240-276-3666

March 4 and 5, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Nature and Basis Statements of Conflict(s) of Interest for March 4-5, 2008 Meeting (html)
  • Agenda for March 4, 2008 (pdf)
  • Agenda for March 5, 2008 (pdf)
  • Roster for March 4, 21008 (pdf)
  • Roster for March 5, 2008 (pdf)
  • Briefing for March 4 and 5, 2008 (html)
  • Draft Questions for March 4 2008 (pdf)
  • Draft Questions for March 5, 2008 (pdf)
  • Minutes for March 4 2008 (pdf)
  • Minutes for March 5, 2008 (pdf)
  • Transcript for March 4 2008: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), Part5 (pdf)
  • Transcript for March 5 2008: Part1 (pdf), Part2 (pdf), Part3 (pdf)

Technical Electronic Product Radiation Safety Standards Committee
Executive Secretary: Richard Kaczmarek (HFZ-240), 240-276-3279

 

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Page last updated: June 4, 2009