AMDM/FDA - OIVD 510(k) WORKSHOP - April 19-20, 2005

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

OIVD Workshop Agenda and Presentations:

Day 1 - April 19, 2005 (Tuesday) 

7:30 - 8:00 AM

Registration

8:00 - 8:15

Welcome and Introduction 

• Don St. Pierre, FDA
• AMDM Representative

8:15 -8:45

Introduction to OIVD

• Don St. Pierre [PowerPoint] [Accessible Text]

8:45 - 9:15

Small Manufacturers Assistance (DSMICA) 

• Bill Sutton [PowerPoint] [Accessible Text]

 9:15 - 10:15

510(k) Regulations 

• Heather Rosecrans [PowerPoint] [Accessible Text]

10:15 - 10:30

Break

10:30 - 12:00

510(k) Review Part I 

510(k) Decision Summaries and eSubmissions 

• Sousan Altaie [PowerPoint] [Accessible Text]

Common Issues with 510(k) Reviews and Labeling

• Avis Danishefsky [PowerPoint] [Accessible Text]
• Sally Hojvat
• Kathleen Whitaker [PowerPoint] [Accessible Text]

12:00 - 1:15 PM

Lunch (not provided)

12:30 - 1:15

Meet & Greet with OIVD Management 

1:15 - 2:45

510(k) Review Part II 

Special and Abbreviated 510(k) submissions 

• Josephine Bautista [PowerPoint] [Accessible Text]

Molecular/Genetic 510(k) Submissions 

• Courtney Harper [PowerPoint] [Accessible Text]

510(k) Combination Product submissions 

• Angel Torres-Cabassa [PowerPoint] [Accessible Text]

2:45 - 3:00

Break 

3:00 - 3:20

Replacement Reagent 

• Jim Callaghan [PowerPoint] [Accessible Text]

3:20 - 3:40

Pre-IDE 

• Sousan Altaie [PowerPoint] [Accessible Text]

3:40 - 4:00

Denovo 

• Ruth Chesler [PowerPoint] [Accessible Text]

4:00 - 4:30

Tips/Strategies on Working with FDA 

• Kathryn Powers [PowerPoint] [Accessible Text]

4:30 - 5:00

User Fees, Q & A, Wrap up 

• Don St. Pierre

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Day 2 - April 20, 2005 (Wednesday)

7:30 - 8:00 AM

Registration 

8:00 - 8:30

CBER Issues 

• Sheryl Kochman [PowerPoint] [Accessible Text]

8:30 - 9:15

Bioresearch Monitoring (BIMO) 

• Matthew Tarosky [PowerPoint] [Accessible Text]

9:15 - 10:00

Health Hazard Evaluation/Recalls 

• Kimber Richter/Claudia Gaffey
• Maureen M. Bernier [PowerPoint] [Accessible Text]

10:00 - 10:15

Break 

10:15 - 10:45

Interacting with Compliance/Case Management 

• Andrea Latish/James Woods [PowerPoint] [Accessible Text]

10:45 - 11:30

Quality Systems Regulations 

• Tonya Wilbon [PowerPoint] [Accessible Text]

11:30 - 12:00

Registration and Listing 

• David Gartner [PowerPoint] [Accessible Text]

12:00 - 12:30

Import/Export

• Casper Uldriks [PowerPoint] [Accessible Text]

12:30 - 12:45

Wrap Up

• James Woods