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U.S. Department of Health and Human Services

Medical Devices

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AMDM/FDA - OIVD 510(k) Workshop

April 21-22, 2009

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


Day 1 – April 21, 2009 (Tuesday)

8:30 - 9:00 AM Registration
9:00 - 9:15

Welcome and Introduction 

  • Don St.Pierre, Acting Director, OIVD
  • Judi Smith, President, AMDM
9:15 - 9:45

 Introduction to OIVD

  • Alberto Gutierrez, Ph.D., Deputy Director, Premarket Program, OIVD
9:45 – 10:00

Diagnostic Network: Opportunities for the industry 

  • Francis Kalush, Ph.D., Diagnostic Network Leader, CDRH, OCD
10:00 - 10:15 Break
10:15 - 10:45

Small Manufacturers Assistance (DSMICA) 

  • Bill Sutton, Deputy Director, DSMICA
10:45 – 11:15

Registration and Listing 

  • David Gartner, Program Analyst, OC
11:15 – 12:15

When to Submit (or not) a 510(k), that is the question! 

  • Heather Rosecrans, Director, 510(k) Staff, ODE
12:15 - 1:30 PM Lunch With the FDA Staff
1:30 – 2:00

Special and Abbreviated 510(k) and Add-to-Files

  • Carol Benson, Associate Director, Division of Chemistry and Toxicology Devices, OIVD
2:00 – 3:30

510(k) Review part I

510(k) Decision Summaries:
A reviewer’s Perspective with Case Studies 

  • Sally Hojvat, Ph.D., Director, Division of Microbiology Devices, OIVD

Software in the World of In Vitro Diagnostics 

  • Andrew Grove, Ph.D., Scientific Reviewer, Division of Microbiology Devices, OIVD
  • Eugene Reilly, Scientific Reviewer, Chemistry and Toxicology Devices, OIVD
3:30– 3:45 Break
3:45 – 4:15

510(k) Review part II

Molecular Diagnostics 510(k) Submissions 

  • Courtney Harper, Ph.D., Associate Director, Division of Chemistry and Toxicology Devices, OIVD
4:15 – 4:45

De Novo 

  • Kate Simon, Ph.D., Scientific Reviewer, Microbiology Devices, OIVD
4:45 – 5:15

510(k) Combination Product & Companion Diagnostics 

  • Joseph Milone , PhD, Biologist, OCP

Day 2 – April 22, 2009 (Wednesday)

8:30 - 9:00 AM Registration
9:00 - 9:30

Bioresearch Monitoring (BIMO) 

  • Veronica Calvin, M.A., Biologist
    Division of Bioresearch Monitoring, OC
9:30 - 10:00

Health Hazard Evaluation/Recalls 

  • Murray Malin, M.D., Medical Officer, DOEA, OC
10:00 - 10:15 Break
10:15 – 10:45

Interacting with Compliance/Case Management 

  • Tara Goldman, Biologist, Consumer safety Officer, OIVD
10:45 – 11:15

Quality System Regulations 

  • Tonya Wilbon, B.S., M(ASCP), Compliance Reviewer, OIVD
11:15 – 11:45

Import/Export

  • Casper Uldriks, JD, MDiv, Associate Director for Regulatory Guidance and Government Affairs, OCD
11:45- 12:15

Tips/Strategies on Working with FDA

  • Judi Smith, President, AMDM
12:15 - 1:30 PM Lunch With the FDA Staff
1:30 – 3:00

Frequently Asked Questions Submitted by the Audience

  • Josephine Bautista, M.S., Associate Director, Division of Hematology and Immunology Devices, OIVD
  • Freddie Poole, M.S., Associate Director, Division of Microbiology Devices, OIVD
  • Elizabeth Mansfield, Ph.D., Policy Analyst, OIVD
  • James Woods, Deputy Director, Patient Safety & Product Quality, OIVD
3:00-3:15 Break
3:15 – 4:30

FDA’s new Statistical Guidance document: an interactive session 

  • Kristen Meier, Ph.D., OSB
4:30 – 5:00

Wrap Up

  • Don St.Pierre, Acting Director, OIVD
5:00-7:00 Dinner Break
7:00-9:00

Pre-IDE Workshop

  • Sousan S. Altaie, Ph.D., Scientific Policy Advisor, OIVD
  • Josie Bautista, M.S., Associate Director, Division of Hematology and Immunology Devices, OIVD
  • Estelle Russek-Cohen, Ph.D., Team Leader, OSB