Regulatory issues related to marker development

Development of clinical laboratory tests (described in this article as “markers” and in vitro devices) is guided by governmental regulation both in the U.S. and abroad. The purpose of the regulation is to assure that products used in medical care are safe, perform reliably, and are effective. This article presents a brief overview of the U.S. regulations and how they affect the clinical studies that must be performed to bring a new test to market. The FDAʹs definitions of safety and effectiveness are provided. The three regulatory classes and the regulatory requirements that are associated with each class are described. An attempt is made to compare the U.S. system with those of Europe and Japan.