Medical Devices

AMDM/FDA - OIVD 510(k) Workshop - April 17-18, 2007

Marriott Bethesda North Hotel and Conference Center
5701 Marinelli Road, N. Bethesda, Maryland

7:30 - 8:00 AM	Registration
8:00 - 8:15	Welcome and Introduction Steve Gutman, FDA Judi Smith, AMDM
8:15 - 8:45	Introduction to OIVD Steve Gutman
8:45 - 9:15	Small Manufacturers Assistance (DSMICA) Bill Sutton
9:15 – 9:45	Registration and Listing David Gartner
9:45 – 10:00	Break
10:00 – 11:30	510(k) Regulations Heather Rosecrans
11:30 – 12:00	Pre-IDE Sousan Altaie
12:00 - 1:00 PM	Lunch (not provided)
1:00 - 2:00	510(k) Review part I 510(k) Decision Summaries: A reviewer’s Perspective with Case Studies Sally Hojvat
2:00 – 3:00	510(k) Review part II Molecular Diagnostics 510(k) Submissions Courtney Harper 510(k) Combination Product Submissions Joseph Milone
3:00 – 3:15	Break
3:15 – 4:00	Overview of Premarket Approval Regulations and Review Processes Patricia Beverly
4:00 – 4:30	De Novo Kate Simon
4:30 - 5:00	Q & A, Wrap Up Josephine Bautista

8:00 - 8:30 AM	Registration
8:30 - 9:15	Bioresearch Monitoring (BIMO) Michael Marcarelli
9:15 - 10:00	Health Hazard Evaluation/Recalls Maureen M. Bernier
10:00 – 10:15	Break
10:15 - 10:45	Interacting with Compliance/Case Management Andrea Latish
10:45 - 11:30	Quality Systems Regulations Tonya Wilbon
11:30 – 12:00	Import/Export Casper Uldriks
12:00 - 1:00 PM	Lunch (not provided)
1:00 – 3:00	510(k) eSubmission, eReview Sousan Altaie Industry Representative Eugene Reilly
3:00 – 3:15	Break
3:15 – 4:00	Tips/Strategies on Working with FDA Judi Smith
4:00 – 4:30	Wrap Up Alberto Gutierrez