On 6 May 2024, the U.S. Food and Drug Administration (FDA) published its highly anticipated 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).

Historically, FDA exercised enforcement discretion for LDTs, declining to impose its device authority over such tests in most instances. Under the new final rule, LDT manufacturers that generally operated outside FDA oversight will now be expected to come into compliance with FDA requirements and controls applicable to their tests. In consideration of this substantial operational and compliance burden, the preamble to the final rule details a phaseout policy under which FDA will gradually end its general LDT enforcement discretion policy in five phases over a four-year period, as follows:

In connection with the final rule, FDA also issued two draft enforcement policies for certain tests offered in response to emergent situations or public health emergencies (PHEs). Despite the potential for legal challenges to the final rule, clinical laboratories should begin thinking about strategies for evaluating whether their LDTs are subject to FDA’s phaseout policy, determining the extent of FDA requirements that apply to such LDTs, and engaging with FDA.

You can read more in our advisory.