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How Clinical Laboratory Tests Get to Market

Sources
This article was written by Cathy Tokarski with additional contributions from:

Fred Lasky, PhD, Director of Diagnostics Compliance for Ortho-Clinical Diagnostics, a division of Johnson & Johnson, Rochester, NY

Robert Murray, PhD, Technical Director for Midwest Diagnostic Pathology at Lutheran General Hospital, Park Ridge, IL

Sue Evans, Vice President of Product Development for Caliper Technologies Corporation

Steven Gutman, MD, Director - Division of Clinical Laboratory Devices, US Food and Drug Administration

David Sundwall, President of the American Clinical Laboratory Association

Elissa Passiment, Executive Director of the American Society for Clinical Laboratory Science

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US Food and Drug Administration: Premarket Approval Applications for In Vitro Diagnostic Devices Pertaining to Hepatitis C Viruses

US Food and Drug Administration: CDRH Consumer Information, Learn if a Medical Device Has Been Cleared by FDA for Marketing

US Food and Drug Administration: Device Advice, Class I/II Exemptions


This article last reviewed on June 20, 2002.
 
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