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AMDM/FDA - OIVD 510(k) Workshop - April 22-23, 2008

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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