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Speaker
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Presentation
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Alberto Gutierrez
OIVD Director
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Introduction to OIVD
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Joe Tartal
DSMICA Branch Chief
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Small Manufacturers Assistance
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David Gartner
Program Analyst, OC
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Registration & Listing
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Heather Rosecrans
Director, ODE
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When to Submit (or not) a 510(k)
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Doug Rheinheimer
Sci Reviewer, DCTD
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Special & Abbreviated 510(k) and Add-to-Files
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Stephanie Akselrod
Reviewer, DMD
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A Reviewer's Perspective with Case Studies
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Andrew Grove, PhD
Sci Reviewer, DMD
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Software in the World of IVDs
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Kellie Kelm
Sci Reviewer, DCTD
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Molecular Diagnostics
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Donna Roscoe, PhD
Sci Reviewer, DMD
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De Novo
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Joseph Milone, PhD
Biologist, OCP
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510(k) Combination Product & Companion Diagnostics
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Judi Smith
AMDM President
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Strategies for Working with FDA
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Zivana Tezak, Assoc Dir for Science & Technology
Kate Simon, Sci Reviewer, DMD
Sally Hojvat, Director, DMD
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PMA Process
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Veronica Calvin, MA
Biologist, Div of Bioresearch Monitoring, OC
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Bioresearch Monitoring (BIMO)
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Tan Nguyen
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Health Hazard Evaluation / Recalls
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Tara Goldman
Biologist, CSO, OIVD
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Interacting with Compliance / Case Managment
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Tonya Wilbon, BS, M(ASCP)
Compliance Reviewer, OIVD
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Quality System Regulations
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David Kalins
Special Assistant to the Director, CDRH, OC
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Import / Export
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FDA Staff
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FAQ Response #1
FAQ Response #2
FAQ Response #3
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Kristen Meier, PhD,
OSB
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FDA's New Statistical Guidance Document : An Interactive Session
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Lea Carrington
Assoc Dir, HPD
|
Hematology: Premarket & Postmarket Findings for Home-Use PT / INR Devices
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| Last Updated May 18, 2010 |
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