AMDM/FDA– OIVD 510(k) WORKSHOP - April 18-19, 2006

The Regency at Double Tree Hotel
1750 Rockville Pike, Rockville, Maryland

Workshop Agenda

Day 1 – April 18, 2006 (Tuesday)

7:30 - 8:00 AM
Registration

8:00 - 8:15
Welcome and Introduction

• Steve Gutman , FDA
• Leif Olson, AMDM

8:15 -8:45
Introduction to OIVD

• Steve Gutman [PowerPoint ] [Accessible Text]

8:45 - 9:15
Small Manufacturers Assistance (DSMICA)

• Bill Sutton [PowerPoint ] [Accessible Text]

9:15 – 9:45
Registration and Listing

• David Gartner [PowerPoint ] [Accessible Text]

9:45 – 10:00
Break

10:00 – 11:00
510(k) Regulations

• Heather Rosecrans [PowerPoint ] [Accessible Text]

11:00 – 12:30
510(k) Review part I

510(k) eSubmission, eReview
• Sousan Altaie [PowerPoint ] [Accessible Text]

510(k) Decision Summaries: A reviewer’s Perspective with Case Studies
• Sally Hojvat [PowerPoint ] [Accessible Text]

12:30 - 1:30 PM
Lunch (not provided)

1:30 – 3:00
510(k) Review part II

Molecular/Genetic 510(k) Submissions
• Courtney Harper [PowerPoint ] [Accessible Text]

510(k) Combination Product submissions
• Angel Torres-Cabassa [PowerPoint ] [Accessible Text]

Overview of Premarket Approval Regulations and Review Processes
• Patricia Beverly [PowerPoint ] [Accessible Text]

3:00 – 3:15
Break

3:15 – 3:45
Pre-IDE

• Sousan Altaie [PowerPoint ] [Accessible Text]

3:45 – 4:00
De Novo

• Kate Simon [PowerPoint ] [Accessible Text]

4:00 - 5:00
Q & A, Wrap up

• Josephine Bautista [PowerPoint ] [Accessible Text]

Day 2 – April 19, 2006 (Wednesday)

7:30 - 8:00 AM
Registration

8:00 - 8:30
CBER/CDRH Review Harmonization efforts

• Sally Hojvat [PowerPoint ] [Accessible Text]

8:30 - 9:15
Bioresearch Monitoring (BIMO)

• Michael Marcarelli [PowerPoint ] [Accessible Text]

9:15 - 10:00
Health Hazard Evaluation/Recalls

• Maureen M. Bernier [PowerPoint ] [Accessible Text]

10:00 - 10:15
Break

10:15 - 10:45
Interacting with Compliance/Case Management

• Andrea Latish [PowerPoint ] [Accessible Text]

10:45 - 11:30
Quality Systems Regulations

• Tonya Wilbon [PowerPoint ] [Accessible Text]

11:30 – 12:00
Import/Export

• Casper Uldriks [PowerPoint ] [Accessible Text]

12:00 - 12:30
Tips/Strategies on Working with FDA

• Cathy Craft [PowerPoint ] [Accessible Text]

12:30 - 12:45
Wrap Up

• Don St. Pierre