Court Decision On LDTs ‘Quite Realistic’ Before May Deadline, Says ACLA Attorney

An attorney representing the ACLA in its lawsuit to stop the US FDA’s final rule on LDTs emerged from a lengthy hearing on the case feeling ‘cautiously optimistic’ and said a decision could come before May.

An alarm clock marked "6 May" vibrates against a pastel pink background.
(Alexa Mat/Shutterstock)

The ongoing saga over the US Food and Drug Administration’s final rule regulating laboratory-developed tests (LDTs) as medical devices may end before 6 May, the deadline for implementing the rule’s first phase.

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