Critics, the US presidential election and a lawsuit are putting the reclassification of laboratory-developed tests (LDT) as medical devices in jeopardy, analysts have said.
The US Food and Drug Administration (FDA) plans to phase out its general enforcement discretion policy for LDTs over a four-year period, with the first phase of its final rule on LDTs due to come into force on 6 May 2025.
Issued on 6 May, the edict has proved controversial. Supporters argue that adopting in vitro diagnostic products (IVDs) as devices under FDA regulation will improve accuracy standards and thus better patient safety. However, opponents are concerned that more red tape could delay access to critical tests and stifle innovation.
These points were expressed at Advamed’s MedTech Conference in Toronto, Canada, from where GlobalData analysts reported that detractors of the final rule were concerned that small laboratories may struggle to meet FDA standards for some tests, particularly those which test complex or rare biological samples.
GlobalData is Medical Device Network’s parent company.
The final rule amends the current FDA regulations to definitively include IVDs as devices, bringing them under the US Federal Food, Drug, and Cosmetic Act (FD&C Act). IVDs now fall under the act, even when the manufacturer of the IVD is a laboratory.
The amendment was introduced alongside plans for a policy giving the FDA greater oversight of IVDs offered as LFTs. This will be achieved through a five-stage phaseout of its general enforcement discretion approach for LDTs, carried out over four years.
From May next year, the FDA will expect compliance with medical device reporting (MDR) requirements, correction and removal reporting requirements and quality system (QS) requirements regarding complaint files. But, the phaseout is causing concerns among some industry players, who see the policy as an obstacle to progress in personalised medicine.
This includes the American Clinical Laboratory Association (ACLA), which filed a case against the FDA on 29 May. ACLA president Susan Van Meter said that the lawsuit was needed because the “FDA’s final rule is the wrong approach, both as a matter of law and public policy and represents regulatory overreach”.
If the lawsuit is successful, the FDA will be forced to change or abandon its rule, putting the four-year phaseout timescale on shaky tracks.
Selena Yu, senior medical analyst at GlobalData, commented: “The future of LDTs transitioning to medical devices is in limbo. This is due to the multi-year process, which can lead to multiple opportunities for litigation that may delay timelines set out by the FDA.”
Of what would change if the ACLA's case is not successful, Yu said: “Assuming that the FDA final ruling for LDTs proceeds as planned, there will be a consolidation of LDTs and smaller clinical labs. This is due to the fact that various clinical labs often use the same manufacturing reagents, adapting them to test for the same indications.”
ACLA’s case is not the only potential spanner in the works for the FDA’s plans, however. Neither the FDA commissioner nor the Human and Health Services (HSS) secretary of the Biden Administration intends to be part of the US Government’s next administration, meaning that a change in leadership is imminent, regardless of the election results.
Yu concluded: “The FDA’s projected multi-year timeline for oversight in LDTs could be delayed as there is ample opportunity for more litigations to arise. It is difficult to predict what will happen in the next few months for LDTs as new leaders enter the White House, FDA, and HHS, which, coupled with the current lawsuit against the FDA, makes the future of LDTs transitioning to medical devices uncertain.”
