FDA Phasing Out Enforcement Discretion on Laboratory Developed Tests and Proposes Regulating Them as Devices

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published a rule in the Federal Register that proposed amending its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, the FDA is proposing a policy under which the FDA intends to phase out its general enforcement discretion approach for laboratory-developed tests (LDTs) so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. FDA asserts that it is taking this step to better protect public health by helping to assure the safety and effectiveness of LDTs.

FDA has requested comments by December 4, 2023.