Speakers

Presentations

Don St. Pierre

OIVD

Introduction to OIVD

Francis Kalush

CDRH, OCD

Opportunities for the Industry

Bill Sutton

DSMICA

Small Mftrs Assistance

David Gartner

OC

Registration and Listing

Heather Rosecrans

ODE

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

Carol Benson

DCTD, OIVD

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

Stefanie Akselrod

DMD, OIVD

510(k) Review Part 1 Decision Summaries: 

A Reviewer's Perspective with Case Studies

Andrew Grove

DMD

Eugene Reilly

DCTD

Software in the World of IVDs

Courtney Harper

DCTD

510(k) Review Part II:  Molecular Diagnostics

Kate Simon

OIVD

DeNovo

Joseph Malone

OCP

510(k) Combination Product & Companion Diagnostics

Veronica Calvin

OC

Bioresearch Monitoring (BIMO)

Murray Malin

DOEA, OC

Health Hazard Evaluation / Recalls

Tara Goldman

OIVD

Interacting with Compliance / Case Management

Tara Goldman

OIVD

Quality System Regulations

Casper Uldricks

OCD

Import / Export

Judi Smith

AMDM

Tips for Working with the FDA

Josephine Bautista

DHID, OIVD

Freddie Poole

DMD, OIVD

Elizabeth Mansfield

OIVD

James Woods

OIVD

Frequently Asked Questions Submitted by the Audience

Kristen Meier

OSB

FDA's New Statistical Guidance Document:  An Interactive Session