FDA Laboratory Developed Tests: Unpacking FDA's Final Rule To Regulate LDTs

On May 6, 2024, the US Food and Drug Administration (FDA) made a landmark decision in the regulation of laboratory-developed tests (LDTs) by issuing a final rule that classifies these tests as medical devices. This pivotal regulation redefines the landscape of diagnostic testing by expanding the definition of in vitro diagnostic (IVD) devices to include tests that are developed and manufactured within laboratories. This change effectively dissolves the long-standing legal and regulatory distinction between IVDs and LDTs.

Laboratories that previously operated under more lenient guidelines will now face stricter oversight, which may involve more rigorous validation processes, quality control measures, and post-market surveillance. This shift aims to enhance the overall quality and reliability of diagnostic tests available to healthcare providers and patients, ultimately improving patient outcomes and public health. In this white paper, learn how this move is expected to foster innovation in the development of new diagnostic tests while ensuring that these tests are safe and effective for clinical use.