Chapter 1 : Role of the U.S. Food and Drug Administration in Regulation of Commercial Clinical Microbiology Products

Abstract:

As the U.S. Food and Drug Administration (FDA) approval process has a major impact on how and when new in vitro diagnostic devices (IVDs) become available for use by the health care professional or the layperson, it is important to examine how the FDA and the Health Care Finance Administration (HCFA) regulatory processes operate. For the purpose of this chapter, examples and cited regulations will for the most part be confined to the FDA process which permits commercial interstate sale and distribution of clinical microbiology IVDs by the Center for Devices and Radiological Health (CDRH). Detection and identification of microorganisms directly from clinical material were in their infancy in 1976 with the exception of antisera conjugated with a fluorescent dye and directed at fastidious organisms, such as Francisella tularensis, Toxoplasma gondii, rickettsiae, or rabies virus. The study should be carefully designed to provide information and data to establish the clinical and analytical accuracy of the assay. Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) extended federal regulation to cover all laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment or for the assessment of the health of human beings. Molecular techniques, such as nucleic acid amplification (NAA), may replace culture as a more sensitive, specific, and rapid method for the identification of specific microorganisms directly from clinical material.