Regulatory issues related to marker development

Development of clinical laboratory tests (described in this article as "mar kers" and in vitro devices) is guided by governmental regulation both in th e U.S. and abroad. The purpose of the regulation is to assure that products used in medical cars are safe, perform reliably, and are effective. This a rticle presents a brief overview of the U.S. regulations and how they affec t the clinical studies that must be performed to bring a new test to market . The FDA's definitions of safety and effectiveness are provided. The three regulatory classes and the regulatory requirements that are associated wit h each class are described. An attempt is made to compare the U.S. system w ith those of Europe and Japan. (C) 2000 Elsevier Science Inc. All rights re served.