On April 29, 2024, the FDA announced a final rule amending regulations to make explicit that In Vitro Diagnostic Devices (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. A Laboratory Developed Test (LDT) is a type of in vitro diagnostic test that is designed, manufactured, and used within a single laboratory. These tests are intended for clinical use and are typically developed by certified clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Along with this amendment, the FDA issued a policy to phase out, its general enforcement discretion approach for LDTs over the course of four years. The agency also issued targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.
The FDA believes that phasing out its general enforcement discretion approach for most LDTs will protect the public health by helping to assure the safety and effectiveness of these tests, while avoiding undue disruption to patient care. Additionally, increased compliance with device requirements under the FD&C Act (such as premarket review, quality system (QS) requirements, adverse event reporting, establishment registration and device listing, labeling requirements, and investigational use requirements) will put patients and health care providers in a better position to have confidence in IVDs regardless of where they are manufactured.
After this phaseout, the FDA generally will expect IVDs to meet the same requirements whether made by a laboratory or not, though certain IVDs manufactured by laboratories may fall within one of the agency’s targeted enforcement discretion policies.
Read the final rule here.
Read the FDA News Release here.
