In our blog post from May this year, we set out what you need to know about the U.S. Food and Drug Administration (FDA) final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture IVDs manufactured by laboratories (known as laboratory developed tests or LDTs).

Following that publication, two cases challenging the FDA’s authority to regulate LDTs were filed.

With a second Trump administration coming in January, we felt an update on the current state of the litigation opposing the LDT rule would be of interest. In our recent Advisory, we briefly summarize the current state of the two consolidated cases against FDA and end with some thoughts on where the new administration’s policy prerogatives may lead us as we seemingly enter yet another chapter in the long history of FDA’s attempts to fully regulate LDTs as medical devices.