FDA LDT Rule
Historically in the U.S., LDTs have been primarily regulated under the Clinical Laboratory Improvement Amendments (CLIA) rather than under the FDA. In April 2024, the FDA announced a rule amending their 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.
On March 31, 2025, a federal court vacated the FDA’s Final Rule asserting regulatory authority over LDTs as medical devices. The ruling halts FDA’s plan to phase out enforcement discretion over four years, affirming that LDT oversight falls under CLIA via CMS, not FDA. Therefore, clinical labs in the United States are not required to comply with FDA device regulations for LDTs.
We provide a wide range of products to help streamline and support clinical laboratory workflows, including GPR-, GPLE- and cGMP-level quality instruments and reagents for nucleic acid purification, PCR, STR analysis, genetic analysis and mutation detection.
