AMDM/FDA - OIVD 510(k) Workshop
April 22-23, 2008
Marriott Bethesda North Hotel and Conference Center
5701 Marinelli Road, N. Bethesda, Maryland
Day 1 - April 22, 2008 (Tuesday)
| 7:30 - 8:00 AM |
Registration
|
| 8:00 - 8:15 |
Welcome and Introduction
- Steve Gutman, MD, MPH, Director, OIVD
- Judi Smith, AMDM President
|
| 8:15 - 8:45 |
Introduction to OIVD
- Alberto Gutierrez, PhD, Deputy Director, Premarket Program, OIVD
|
| 8:45 - 9:15 |
Small Manufacturers Assistance (DSMICA)
- Bill Sutton, Deputy Director, DSMICA
|
| 9:15 – 9:45 |
Registration and Listing
- David Gartner, Program Analyst, OC
|
| 9:45 – 10:00 |
Break |
| 10:00 – 11:30 |
510(k) Regulations
- Heather Rosecrans, Director, Premarket Notification, 510(k) Staff, ODE
|
| 11:30 – 12:00 |
Pre-IDE
- Sousan Altaie, PhD, Scientific Policy Advisor, OD, OIVD
|
| 12:00 - 1:00 PM |
Lunch With FDA Staff
|
| 1:00 - 2:00 |
510(k) Review part I
510(k) Decision Summaries:
A reviewer’s Perspective with Case Studies
- Uwe Scherf, PhD, Associate Director, Division of Microbiology Devices, OIVD
|
| 2:00 – 3:00 |
510(k) Review part II
Molecular Diagnostics 510(k) Submissions
- Courtney Harper, PhD, Associate Director, Division of Chemistry and Toxicology Devices, OIVD
510(k) Combination Product Submissions
- Joseph Milone, PhD, Biologist, OCP
|
| 3:00 – 3:15 |
Break |
| 3:15 – 4:00 |
Interactive Review Guidance Document
- Patricia Beverly, MT, Public Health Analyst, OIVD
|
| 4:00 – 4:30 |
De Novo
- Kate Simon, PhD, Scientific Reviewer, OIVD
|
| 4:30 - 5:00 |
Q & A, Wrap Up
- Josephine Bautista, MS, Associate Director, Division of Hematology and Immunology Devices, OIVD
|
Day 2 - April 23, 2008 (Wednesday)
| 7:30 - 8:00 AM |
Registration |
| 8:00 - 8:30 |
Bioresearch Monitoring (BIMO)
- CDR Matthew Tarosky, PharmD., Deputy Director Division of Bioresearch Monitoring, OC
|
| 8:30 - 9:00 |
Health Hazard Evaluation/Recalls
- Murray Malin, M.D., Medical Officer, DOEA, OC
|
| 9:00 – 9:30 |
Interacting with Compliance/Case Management
- Tara Goldman, Biologist, Consumer Safety Officer, OIVD
|
| 9:30 - 10:15 |
Quality Systems Regulations
- Tonya Wilbon, BS, M(ASCP), Compliance Reviewer, OIVD
|
| 10:15 - 10:30 |
Break
|
| 10:30 – 11:00 |
Import/Export
- Casper Uldriks, JD, MDiv, Associate Director for Regulatory Guidance and Government Affairs,OCD
|
| 11:00 - 12:00 |
Tips/Strategies on Working with FDA
- Judi Smith, AMDM President
|
| 12:00 - 1:00 PM |
Lunch With FDA Staff
|
| 1:00 – 3:00 |
510(k) eSubmission Hands-on Training (Part I)
(Please bring your laptops. The FDA will provide disks for you to load software for this interactive session.)
- Danielle Hangen, CeSub Deputy Project Manager
- Sousan Altaie, Ph.D. Scientific Policy Advisor, OD, OIVD
- Eugene Reilly, Scientific Reviewer, OIVD
- CDR Michael Coene, Acting Branch Chief, Evaluating Technology Branch, Division of Technology, OIM
|
| 3:00 – 3:15 |
Break |
| 3:15 – 4:30 |
510(k) eSubmission Hands-on Training (Part iI)
(Please bring your laptops. The FDA will provide disks for you to load software for this interactive session.)
- Danielle Hangen, CeSub Deputy Project Manager
- Sousan Altaie, Ph.D. Scientific Policy Advisor, OD, OIVD
- Eugene Reilly, Scientific Reviewer, OIVD
- CDR Michael Coene, Acting Branch Chief, Evaluating Technology Branch, Division of Technology, OIM
|
| 4:30– 5:00 |
Wrap Up
- Alberto Gutierrez, PhD, Deputy Director, Premarket Program, OIVD
|
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