The Current State of the U.S. Food and Drug Administration Process and Regulations for Diagnostic Laboratory Assays

Abstract

The United States (US) Food and Drug Administration (FDA) regulates the sale and distribution of in vitro diagnostic devices (IVDs), commonly referred to as laboratory assays or laboratory tests. This chapter provides an overview of (i) the FDA process for risk-based classification and regulation of IVDs, (ii) the FDA methods used to assess performance of IVDs prior to their clearance or approval for release in marketing and distribution to diagnostic laboratories, (iii) the laws that impact clinical laboratories that are participating in FDA clinical trials, and (iv) the process by which the FDA conducts postmarket regulation of IVDs and associated postmarket performance. The chapter helps the reader to understand the process by which the FDA approves a laboratory assay, and describes the different processes used during FDA review. It also describes the risk categories the FDA uses to determine the type of process for review. The chapter also helps the reader to understand the premarket approval (PMA) forms, requirements, and process, and the need to recognize the importance of good clinical practices (GCPs), good manufacturing practices (GMPs), and quality systems regulations (QSR) in the FDA approval process. It talks about the requirements related to 510(k) notification to the FDA, the pre-investigational device exemption process, and the part that the Office of In Vitro and Radiological Health plays during the approval process. Finally, the chapter reviews the limitations inherent to current FDA processes.