title: 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.
authors: Epstein Becker & Green, PC, 1227 25th Street Northwest, Suite 700, Washington, DC 20037, USA.
authors: Bradley Merrill
authors: BM
authors: Thompson
authors: Epstein Becker & Green, PC, 1227 25th Street Northwest, Suite 700, Washington, DC 20037, USA.
authors: Bonnie I
authors: BI
authors: Scott
authors: Epstein Becker & Green, PC, 1227 25th Street Northwest, Suite 700, Washington, DC 20037, USA. Electronic address: jboiani@ebglaw.com.
authors: James A
authors: JA
authors: Boiani
mesh_terms: D064790:Clinical Laboratory Services / Q000331:legislation & jurisprudence*; D003358:Cosmetics; D007880:Legislation, Drug; D007881:Legislation, Food; D004364:Pharmaceutical Preparations; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D003358:Cosmetics; D004364:Pharmaceutical Preparations
keywords: CLIA; FDA; IVD; LDT; Laboratory tests; Laboratory-developed test