In May 2024, the US Food and Drug Administration (FDA) issued its 鈥楩inal Rule鈥�, asserting that laboratory-developed tests (LDTs) – otherwise known as in vitro diagnostics (IVDs) – were medical devices and would therefore be regulated under the same standards.
The agency鈥檚 regulation provoked outcry. At the time, American Clinical Laboratory Association (ACLA) president Susan Van Meter said the medical device framework was 鈥渋nappropriate and ill-suited鈥� as a means of regulating LDTs given they are most often services provided by trained professionals rather than manufactured products for wide commercial release.
鈥淭hese professional services incorporate the latest scientific advances to offer innovative testing solutions to physicians and the patients they serve,鈥� Van Meter said.
鈥淭he Rule will disrupt this paradigm, creating negative consequences for the entire health care system, including millions of vulnerable patients who depend on the essential clinical testing services that only laboratory professionals can provide.鈥�
Others such as the (AHA) held similarly negative sentiments, agreeing that regulating LDTs in the same manner as medical devices did not make sense. However, there has been some recognition that something to supersede the Clinical Laboratory Improvement Amendments of 1988 (CLIA regulations), albeit not medical device regulation, could make sense as a means to account for the changing nature of LDTs since the initial regulation came into effect.
The Final Rule was mooted for implementation over a , determined by a service鈥檚 risk level, by 2028. Not least because of the change and the potential that convenient protocols within private labs may be subject for erosion, the Final Rule also drew ire given that costs incurred for those developing LDTs, to fall into the various qualitative edicts for their LDTs akin to medical devices, such as post-market quality (PMQ) reviews and more, would prove a considerable expenditure and headache on the paperwork front.
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By GlobalDataOn 1 April 2025, the lab industry breathed a collective sigh of relief when a Texas judge ruled against the FDA in a lawsuit filed by the American Clinical Laboratory Association (ACLA), member company HealthTrackRx, and the Association for Molecular Pathology (AMP) at the US District Court for the Eastern District of Texas in 2024.
US judge Sean Jordan set aside the case in its entirety. In the memo on his verdict, Jordan said the existing Clinical Laboratory Improvement Amendments (CLIA) under which LDTs have long been regulated were already sufficient and that the 鈥渢ext, structure, and history鈥� of the FDCA and CLIA make clear that the 鈥淔DA lacks the authority鈥� to regulate laboratory-developed test services.
Commenting on its court win, the AMP said at the time: 鈥淚f it had been left in place, the FDA鈥檚 Final Rule would have classified LDTs as medical devices, creating unwarranted regulatory roadblocks that could have increased costs, hindered innovation and limited patient access to critical diagnostic tools.
鈥淚mportantly, this ruling reinforces the vital role of laboratory professionals in driving advancements in precision medicine.鈥�
Response to the outcome
According to Sarah Moore, principal project lead, medical devices in the National Sanitation Foundation鈥檚 (NSF) life sciences division, the degree of relief over the court ruling depends on what part of the broader LDT industry an entity is focused on.
鈥淭he final ruling definitely had a big impact on the CLIA labs and academic institutions, and in the more corporatised reference labs, but it didn’t have as big of an operational impact on medical device manufacturers, and we know that very few of the LDTs on the market or in use come from traditional medical device manufacturers,鈥� she explains.
鈥淚 think there is some sigh of relief over this ruling from the academic institutions and reference labs, given that they weren’t really structured to comply with this new ruling in their primary resource organisations.鈥�
What now?
While the court ruling has been met with relief throughout the laboratory community, the story is still unfolding as the FDA has up to 60 days from the ruling鈥檚 date to appeal the court鈥檚 decision.
In the view of Torrey Cope, partner in Sidley’s Food, Drug, & 彩神vlll争霸 practice, labs are in something of a 鈥渓imbo鈥�, waiting to see what will happen next.
鈥淚 think everybody was waiting to see how the challenge would play out and kind of making plans to come into compliance in case the challenge wasn’t successful,鈥� says Cope.
鈥淎nd I think it鈥檚 still a case of 鈥榳ait and see鈥�, because the next step is to find out if the FDA and US Department of Justice (DOJ) are going to appeal the decision.鈥�
Impact of a new administration
Donald Trump recently passed 100 days in office. During that time, Robert F Kennedy, Jr (RFK Jr), secretary of the US Department of Health & Human Services (HHS), has taken an axe to the health agencies nested under the HHS, culling the agencies鈥� combined workforce from 82,000 to around 62,000. This raises the question of whether challenging the court ruling is a priority for the FDA and whether it has the bandwidth at this time to mount a challenge.
In a typical situation, you would expect the agency to appeal [the court ruling], Cope adds, but at this time, the prospect of any appeal is 鈥渞eally hard to predict鈥�.
鈥淭he FDA went to the effort to promulgate a Final Rule, and it’s been challenged. The normal course would be to keep going and appeal that challenge.
鈥淏ut, from a political perspective, while the desire to pursue the policy was evidently appealing under the Biden administration, we haven’t had a clear read from the Trump Administration either way.鈥�
Further weighing against an appeal is that, in Cope鈥檚 view, the 鈥楳ake America Healthy Again鈥� ideology espoused by RFK Jr may mean the FDA is unsupportive of challenging the ruling.
鈥淪o, there are several variables to consider, but unfortunately, no clear answer, or no clear direction on what to expect at this time,鈥� Cope concludes.
Under the Trump administration, priorities may have shifted, Moore notes, and so we don’t know enough to predict whether an appeal by the FDA will be forthcoming.
鈥淏ut I do think this is a great opportunity to better understand what Secretary Kennedy’s priorities will be in this administration,鈥� says Moore.
鈥淚t could serve as a bellwether to predict his stance on future regulation and enforcement activities. I think it will serve as a predictor either way, since we’re still learning where he stands and what he believes his agency should focus on.鈥�
Whether the FDA鈥檚 Final Rule ends up taking effect, in the near future or longer-term future in a different form, the increased awareness of how any modern surveillance system could look, as prompted by the ruling鈥檚 introduction, is potentially a positive.
Cope points out that tests today have evolved considerably since the CLIA Act was put in place.
Lots has changed with LDTs since that body of law was introduced, Cope says, and while the device scheme for LDTs seemed a 鈥渂it of an odd fit鈥�, there are questions from some around whether LDTs should be regulated, whether there should be more oversight, and if so, who should be fulfilling that role 鈥� all questions that the Final Rule has generated discussion around.
鈥淓ven if the ruling doesn’t go into effect, I think it’s still good for patients in so much as it鈥檚 given more attention to considerations around the quality and performance of individual tests,鈥� says Moore.
鈥淭here’s time now to consider how best to do that with the vacation of this ruling.鈥�
