AMDM/FDA– OIVD 510(k) WORKSHOP
April 18-19, 2006
The Regency at Double Tree Hotel
1750 Rockville Pike, Rockville, Maryland
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
8:45 - 9:15
Small Manufacturers Assistance (DSMICA)
9:15 – 9:45
Registration and Listing
9:45 – 10:00
Break
10:00 – 11:00
510(k) Regulations
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
3:45 – 4:00
De Novo
4:00 - 5:00
Q & A, Wrap up
Day 2 – April 19, 2006 (Wednesday)
7:30 - 8:00 AM
Registration
8:00 - 8:30
CBER/CDRH Review Harmonization efforts
8:30 - 9:15
Bioresearch Monitoring (BIMO)
9:15 - 10:00
Health Hazard Evaluation/Recalls
10:00 - 10:15
Break
10:15 - 10:45
Interacting with Compliance/Case Management
10:45 - 11:30
Quality Systems Regulations
11:30 – 12:00
Import/Export
12:00 - 12:30
Tips/Strategies on Working with FDA
12:30 - 12:45
Wrap Up
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