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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
