The much-anticipated FDA Final Rule on enforcement of IVD (in vitro diagnostic) regulations for Laboratory Developed Tests (LDTs) has been released. The rule describes the previously proposed five stages of enforcement over four years and provides updates to the FDA’s enforcement discretion policy for certain IVDs, including LDTs approved by New York State and LDTs validated prior to the publication of the final rule. With the announcement comes many questions and concerns about the future of LDTs and how laboratories will navigate the changes.

As a provider of both services and software for a large community of laboratories running LDTs, Velsera is focused on how we can best support our customers during this transition to more stringent regulatory standards while maintaining the highest level of patient care. Let's continue to collaborate and innovate as we navigate these dynamic landscapes together!