New FDA Guidance on Laboratory Developed Tests (LDTs)
Today, the U.S. Food and Drug Administration (FDA) announced significant action to enhance the safety and effectiveness of laboratory developed tests (LDTs), which are increasingly utilized in healthcare decisions. LDTs, defined as in vitro diagnostic products (IVDs) developed, manufactured, and used within a single clinical laboratory, play a crucial role in healthcare by providing information about a patient’s health and guiding treatment decisions.
The FDA's final rule explicitly categorizes IVDs as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), even when manufactured by laboratories. Additionally, the agency issued policies to phase out its general enforcement discretion approach for LDTs over four years, aiming to address concerns about the safety and accuracy of these tests.
Historically, the FDA exercised enforcement discretion for most LDTs. However, the increased use and complexity of modern LDTs pose greater risks, including inaccurate results and patient harm. With these new measures, the FDA seeks to ensure that healthcare decisions are based on reliable test results and promote health equity.
The impact of these changes will extend across various stakeholders in the healthcare ecosystem. Manufacturers, Group Purchasing Organizations (GPOs), and National Reference Laboratories will need to adapt to the evolving regulatory landscape to ensure compliance with device requirements and maintain patient access to critical tests. As the FDA transitions from enforcement discretion to increased oversight, stakeholders must stay informed and proactive in navigating these changes to support patient safety and quality care.
For more information on the FDA's guidance and related resources, visit the FDA's website.
The FDA, an agency within the U.S. Department of Health and Human Services, safeguards public health by ensuring the safety, effectiveness, and security of medical products and food.