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.

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.

Summary of DIA Workshop on Co-Development of Personalized Medicine and In Vitro Diagnostic Companion Devices.

The pairing of personalized medicine, including targeted drug therapy, and in vitro diagnostic (IVD) companion devices (ie, "companion diagnostics") allows treatment decisions to be tailored for each patient. However, development of companion diagnostics and personalized medicine still faces challenges in clinical development as regulatory policy tries to keep up with and accommodate this growing field. To assist industry and regulators, the DIA provided a forum for the discussion of current challenges and opportunities for progressive alignment approaches to regulating personalized medicine and IVD devices.