May 6, 2024- The U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years.
LDTs are in vitro diagnostic products (IVDs) that the FDA has described as intended for clinical use and designed, manufactured and used within a single clinical laboratory that meets certain regulatory requirements. IVDs can play an important role in health care; they are used in the collection, preparation and examination of specimens taken from the human body, such as blood, saliva or tissue. They can be used to measure or detect substances or analytes, such as proteins, glucose, cholesterol or DNA, to provide information about a patient’s health, including to identify, monitor or determine treatment for diseases and conditions.
The FDA announced a final rule today amending the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA issued a policy to phase out, over the course of four years, its general enforcement discretion approach for LDTs. The agency also issued targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.