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Agenda
IVD ROUNDTABLE - 510(k)/OIVD Workshop
April 20 - 21, 2004
The Washington Theater, Double Tree Hotel
1750 Rockville Pike, Rockville, Maryland

[Back to Presentations]

 

Presentations are available on the web. A link follows the name of the presenter.

Day 1 - April 20, 2004 (Tuesday)

7:30 - 8:00 AM Registration
8:00 - 8:15

Welcome and Introduction
8:15 - 8:45

Introduction to OIVD

  • Don St. Pierre
8:45 - 9:15

Small Manufacturers Assistance (DSMICA)
9:15 - 10:00

510(k) Regulations
10:00 - 10:15 Break
10:15 - 10:30

Types of 510(k) s/Expectations
10:30 - 12:00

510(k) Review

Administrative Elements
• Carol Benson [PowerPoint] [Text]

Analytical Elements
• Josephine Bautista [PowerPoint] [Text]

Clinical Elements
• Sally Hojvat [PowerPoint] [Text]

Specific Immunohistochemical Elements
• Nina Chace [PowerPoint] [Text]
12:00 - 12:30 Lunch (on your own)
12:30 - 1:00 PM

FDA/OIVD Breakout Chat Sessions (Meet and Greet: Product Specific Q&A)

- Division of Microbiology Devices
- Division of Immunology/Hematology
- Division of Chemistry/ Toxicology
1:00 - 1:30

CLIA '88
1:30 - 2:00

Denovo
2:00 - 2:15 Break
2:15 - 2:45

Pre-IDE
2:45 - 3:15

Tips/Strategies on Working with FDA
3:15 - 3:45

Bundling
3:35 - 3:55

Replacement Reagent
3:55 - 4:15

Software
   
Day 2 – April 21, 2004 (Wednesday)
 
7:30 - 8:00 AM Registration
8:00 - 8:30

CBER Issues
8:30 - 9:15

Bioresearch Monitoring (BiMo)
9:15 - 10:15

Health Hazard Evaluation
10:15 -10:30 Break
10:30 – 11:00

Interaction with Compliance/Case Management
11:00 – 11:45

Quality Systems Regulations
11:45– 12:15

Registration and Listing
12:15 - 12:45

Import/Export
12:45 - 1:00

Wrap Up

  • James Woods

Updated May 11, 2004

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