Understanding the Food and Drug Administration's Jurisdiction Over Laboratory-Developed Tests and Divisions Between Food, Drug, and Cosmetic Act-Regulated and Clinical Laboratory Improvement Amendments of 1988-Regulated Activities

Abstract

The scope of FDA's jurisdiction over laboratory-developed tests (LDTs), and whether FDA has such jurisdiction at all, has been a heavily debated issue over the past several years. If FDA moves forward with its guidance, or Congress takes action to reform LDT and IVD regulation, a fundamental question that needs to be answered is how to divide activities regulated by FDCA from those regulated by CLIA. In this article, we consider FDA's authority to regulate LDTs and the policy implications of regulation, and discuss an idea for a fact-driven framework to distinguish FDCA- and CLIA- activities.

Keywords: CLIA; FDA; IVD; LDT; Laboratory tests; Laboratory-developed test.