Litigation against the FDA’s Final Rule on lab-developed tests (LDTs) is causing uncertainty to rise as the US regulator gears up for a legal clash with the lab industry.

Since the FDA revealed its controversial Final Rule on LDTs, two laboratory associations have filed lawsuits which are now pending in one consolidated case in the U.S District Court for the Eastern District of Texas.

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During a panel discussion at Advamed’s MedTech Conference in Toronto, industry leaders gathered to discuss the future of diagnostics regulation.

The first deadline for the LDT rule transition timeline is May 6, 2025, and while manufacturers have been watching to see if a preliminary injunction could be introduced that blocks implementation of the rule while the case is pending, it is yet to happen.

“It could be that as we get closer to the first stage one phase of the Final Rule implementation on May 6, 2025, if the case is not decided, the plaintiff may do that,” said Nathan Brown, Partner at law firm Akin Gump Strauss Hauer & Feld LLP. “But as of now, FDA is proceeding with implementation of the rule.”

With no fixed deadline for the Court to rule, manufacturers are expected to proceed with business as usual.

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“The bottom line is there is a long trajectory for this case,” said Brown. “We don’t know what’s going to happen and there will be multiple steps.”

Bracing for chaos

Amid the controversy, Scott Garrett, Operating Partner at Water Street Healthcare Partners said he believed there were favourable elements of the LDT legislation for the lab industry.

“It was 1976 when the Device Act was passed in the US and there was never any real thought to why diagnostics were included, so it was time for an update,” said Garrett.

“We saw with the VALID Act, how some organisations opposed the Act more so due to principle and wanting to stop the FDA having more authority, but because of that they actually missed that there were merits to the legislation.”

Garrett shared that he expected it to be a ‘train wreck in the courts’ and regardless of the Court’s decision, chaos could ensue.

“It going to create a big mess,” Garrett said. “My advice to industry is to absolutely understand the Final Rule and be in compliance all the time. I expect the ruling is going to be around for awhile, and you don’t want to become a poster child for what happens when you ignore something like this.”