Laboratory-Developed Tests: FDA Publishes Highly Anticipated Proposed Rule

On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as medical devices. It has long been FDA’s position that the Food, Drug, and Cosmetic Act gives it authority to regulate LDTs as medical devices. Historically, FDA has exercised enforcement discretion with respect to most LDTs and has not required the laboratories offering such…
By: McDermott Will & Emery