On May 14, 2024, the U.S. Food and Drug Administration (FDA) is hosting a webinar to discuss the final rule “Medical Devices; Laboratory Developed Tests” (LDTs). FDA will provide an overview of the final rule amending the FDA’s regulations to make it explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory; and describe the phaseout of the FDA’s general enforcement discretion approach to LDTs.
Please visit the CDC LOCS page for more information and a link to the webinar.