AMDM/FDA - OIVD 510(k) Workshop
April 21-22, 2009
Marriott Bethesda North Hotel and Conference Center
5701 Marinelli Road, N. Bethesda, Maryland
Day 1 – April 21, 2009 (Tuesday)
| 8:30 - 9:00 AM |
Registration
|
| 9:00 - 9:15 |
Welcome and Introduction
- Don St.Pierre, Acting Director, OIVD
- Judi Smith, President, AMDM
|
| 9:15 - 9:45 |
Introduction to OIVD
- Alberto Gutierrez, Ph.D., Deputy Director, Premarket Program, OIVD
|
| 9:45 – 10:00 |
Diagnostic Network: Opportunities for the industry
- Francis Kalush, Ph.D., Diagnostic Network Leader, CDRH, OCD
|
| 10:00 - 10:15 |
Break
|
| 10:15 - 10:45 |
Small Manufacturers Assistance (DSMICA)
- Bill Sutton, Deputy Director, DSMICA
|
| 10:45 – 11:15 |
Registration and Listing
- David Gartner, Program Analyst, OC
|
| 11:15 – 12:15 |
When to Submit (or not) a 510(k), that is the question!
- Heather Rosecrans, Director, 510(k) Staff, ODE
|
| 12:15 - 1:30 PM |
Lunch With the FDA Staff
|
| 1:30 – 2:00 |
Special and Abbreviated 510(k) and Add-to-Files
- Carol Benson, Associate Director, Division of Chemistry and Toxicology Devices, OIVD
|
| 2:00 – 3:30 |
510(k) Review part I
510(k) Decision Summaries:
A reviewer’s Perspective with Case Studies
- Sally Hojvat, Ph.D., Director, Division of Microbiology Devices, OIVD
Software in the World of In Vitro Diagnostics
- Andrew Grove, Ph.D., Scientific Reviewer, Division of Microbiology Devices, OIVD
- Eugene Reilly, Scientific Reviewer, Chemistry and Toxicology Devices, OIVD
|
| 3:30– 3:45 |
Break
|
| 3:45 – 4:15 |
510(k) Review part II
Molecular Diagnostics 510(k) Submissions
- Courtney Harper, Ph.D., Associate Director, Division of Chemistry and Toxicology Devices, OIVD
|
| 4:15 – 4:45 |
De Novo
- Kate Simon, Ph.D., Scientific Reviewer, Microbiology Devices, OIVD
|
| 4:45 – 5:15 |
510(k) Combination Product & Companion Diagnostics
- Joseph Milone , PhD, Biologist, OCP
|
Day 2 – April 22, 2009 (Wednesday)
| 8:30 - 9:00 AM |
Registration
|
| 9:00 - 9:30 |
Bioresearch Monitoring (BIMO)
- Veronica Calvin, M.A., Biologist
Division of Bioresearch Monitoring, OC
|
| 9:30 - 10:00 |
Health Hazard Evaluation/Recalls
- Murray Malin, M.D., Medical Officer, DOEA, OC
|
| 10:00 - 10:15 |
Break
|
| 10:15 – 10:45 |
Interacting with Compliance/Case Management
- Tara Goldman, Biologist, Consumer safety Officer, OIVD
|
| 10:45 – 11:15 |
Quality System Regulations
- Tonya Wilbon, B.S., M(ASCP), Compliance Reviewer, OIVD
|
| 11:15 – 11:45 |
Import/Export
- Casper Uldriks, JD, MDiv, Associate Director for Regulatory Guidance and Government Affairs, OCD
|
| 11:45- 12:15 |
Tips/Strategies on Working with FDA
- Judi Smith, President, AMDM
|
| 12:15 - 1:30 PM |
Lunch With the FDA Staff
|
| 1:30 – 3:00 |
Frequently Asked Questions Submitted by the Audience
- Josephine Bautista, M.S., Associate Director, Division of Hematology and Immunology Devices, OIVD
- Freddie Poole, M.S., Associate Director, Division of Microbiology Devices, OIVD
- Elizabeth Mansfield, Ph.D., Policy Analyst, OIVD
- James Woods, Deputy Director, Patient Safety & Product Quality, OIVD
|
| 3:00-3:15 |
Break
|
| 3:15 – 4:30 |
FDA’s new Statistical Guidance document: an interactive session
- Kristen Meier, Ph.D., OSB
|
| 4:30 – 5:00 |
Wrap Up
- Don St.Pierre, Acting Director, OIVD
|
| 5:00-7:00 |
Dinner Break
|
| 7:00-9:00 |
Pre-IDE Workshop
- Sousan S. Altaie, Ph.D., Scientific Policy Advisor, OIVD
- Josie Bautista, M.S., Associate Director, Division of Hematology and Immunology Devices, OIVD
- Estelle Russek-Cohen, Ph.D., Team Leader, OSB
|
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