• Meeting Information
• Location and Registration
• Agenda

 Meeting Information

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM) are co-sponsoring the IVD Roundtable 510(k) Workshop April 22-23, 2003 at FDA’s Parklawn Building, Conference Room D, Rockville.

The IVD roundtable is a group of FDA and In Vitro Diagnostics Industry trade association representatives whose mission is to improve communications between FDA and the regulated industry. In its meetings held quarterly since 1995, the Roundtable members have identified areas where improved communications could have substantial benefits for both parties. The Roundtable provides a forum for successfully addressing difficult policy and scientific issues related to the regulation of IVDs. In a period of policy development, rapid technological advancements, as well as congressional mandates, the need for the agency to foster and maintain consistent and dynamic lines of communication with regulated industry, professional organizations, and academia is greater than ever before.

Established in 1973, the Association of Medical Diagnostics Manufacturers (AMDM) is a nonprofit trade association that serves as a resource for education and information on compliance issues between member companies, and as an interface between member companies and the FDA. Today membership includes companies of all sizes who manufacture and distribute; in vitro diagnostic products, including cell cultures and cell culture media, immunology and immune status test products, antigen and microbial detection products, and toxicology

AMDM is a member of the IVD Roundtable and sponsors the 510(k) Workshop in conjunction with its Annual Meeting.

The objectives of the IVD Roundtable 510(k) Workshop are to foster communication between the professional, manufacturing and regulatory community. This interactive workshop provides an opportunity to hear about 510(k) submissions from the FDA people who actually review your submissions. Helpful tips and guidance from experienced industry regulatory affairs personnel will also be provided.

Focused toward the regulatory submissions "beginner" who has little direct experience in preparing 510(k) submissions, this workshop is intended to provide the fundamentals for 510(k) for in vitro diagnostic devices regulated by CDRH/OIVD and CBER. In addition to providing substantive information on 510(k) requirements specific to in vitro diagnostics, workshop participants will have an opportunity to review examples of actual 510(k) submissions, including those that work and those that don't.

 Location and Registration

This two-day workshop will be held at FDA’s Parklawn Building, Conference Room D in Rockville, MD and will be limited to 100 participants. To register for this workshop go to:
http://www.amdm.org/AMDM/021303-IVD-510kProgram.html

 Meeting Agenda

IVD ROUNDTABLE - OIVD Workshop – April 22-23, 2003
Parklawn Building – Conference Room “D”
Agenda

Tuesday – April 22, 2003

8:00 - 8:30 Welcome and Introduction
Patricia Shrader, President, AMDM
Don St.Pierre, Deputy Director, FDA/CDRH/OIVD

8:30 - 9:00 Introduction to OIVD
Don St.Pierre

9:00 - 9:30 DSMICA
Bill Sutton

9:30 - 10:30 510(k) Regulations
Marjorie Shulman

BREAK – 15 Minutes

10:45 - 12:00 510(k) Review 
Traditional – Selective Review Staff - Freddie Poole
Special (tie to design control concepts and TPLC) - Josie Bautista or designate
Abbreviated (tie to the importance of and need for standards) Veronica Calvin
De novo – Carol Benson

12:00 - 1:00 Lunch

1:00 - 1:30 CLIA '88
Clara Sliva

BREAK – (15 Minutes)

1:45 – 3:15 Interacting with the FDA
Pre-IDE process - Josephine Bautista/Sousan Altaie - (30 Minutes)
How to work with FDA from an industry perspective - Mark Del Vecchio - (30 Min)
How to work with Industry from an FDA Perspective - Freddie Poole - (30 Min)

3:15 – 4:00 User Fees
Jim Norman - (15 Minutes)
Bundling – Jim Callaghan - (15 Minutes)
Replacement reagent policy – Jim Callaghan - (15 Minutes)

4:00 – 5:00 Q&A
FDA Panel

Adjourn for the DAY

Wednesday – April 23, 2003

8:00 - 9:30 Compliance
Registration and Listing Processes - Byran Benesch - (15 Minutes)
Bioresearch monitoring - Mike Marcarelli - (15 Minutes)
Inspections, case management, interacting with compliance - James Woods (30 Min)
Recalls - Wendy Sanhai (15 Minutes)
Health Hazard Evaluations - Claudia Gaffey (15 Minutes)

9:30 - 10:00 CBER Issues
Sheryl Kochman

BREAK (20 minutes)

10:20 - 11:00 Labeling
Use of symbols – Carolyn Jones – (30 Minutes)
Electronic labeling – Terri Garvin – (10 Minutes)

11:00 - 11:30 Standards
Ginette Michaud

11:30 - 12:00 Final Q&A and Wrap-up
Steve Gutman