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.

We are committed to supporting clinical labs as they navigate the new FDA rule. We share a collective goal with you of supporting and advancing patient care. Should you need support now or in the future, please reach out to us at SCCMTeam@promega.com.

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. View our 80+ IVDs and GPRS (General Purpose Reagents).