In Vitro Diagnostics: The Complete Regulatory Guide

April 2010

This practical guidebook is the most comprehensive resource published on the burgeoning field of in vitro diagnostics, which increasingly occupies a central place in our healthcare system. Companies are investing great sums to develop and commercialize innovative diagnostic devices. Yet, the legal requirements surrounding IVD remain, in many ways, opaque.

This book brings together all of the disparate sources of information that inform our regulatory system on this often controversial issue. While the primary focus of this book is to describe in detail and in user-friendly terms, the regulatory requirements for IVDs, it does not shy away from the thorny public policy issues.

The authors who contributed to this guidebook have decades of experience advising IVD manufacturers and clinical laboratories, working with or in regulatory agencies and helping to bring innovative IVD devices and diagnostic tests to the market. Simply put, if you’re looking for that single resource on IVD regulation and policy, this book is designed to meet that need.


Author: Scott D. Danzis and Ellen J. Flannery, Editors
Cover: Softcover
Number of pages: 263 pages
Edition: 1st
Date published: Apr 21, 2010
ISBN: 978-1-935065-22-7
Language: English


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