The American Hospital Association (AHA) is pushing back on a proposed FDA rule to regulate diagnostic tests developed in hospital and health system laboratories, claiming it would “pose nearly unsurmountable burdens and costs” for both the labs and the agency.
The rule, which the FDA proposed in September 2023, would allow the agency to regulate laboratory developed tests, or LDTs, in the same manner it regulates medical devices. The FDA says it needs to regulate the tests to make sure they’re safe and accurate, while the hospital trade group claims FDA regulation would be exceedingly costly and stifle innovation.
“While we support the need for additional oversight of the development and use of some LDTs and in-vitro diagnostics (IVDs) offered as LDTs, the FDA’s proposal to apply its device regulations to hospital and health system LDTs is misguided,” Stacey Hughes, EVP of government relations and public policy at the AHA, wrote in a letter sent to Senator Bill Cassidy, a Louisiana Republican and ranking member of the Health, Education, Labor, and Pensions Committee, on April 1.
What exactly are LDTs? Hospitals and health systems sometimes have in-house labs that develop tests for conditions for which there are no commercially distributed tests, like cancer or rare diseases, according to the AHA.
The tests are often developed at a clinician’s request and give the providers “important clinical information to diagnose and treat patients,” Hughes wrote in the letter.
The FDA’s side: The agency claims it wants to regulate the tests as medical devices because it is “increasingly concerned that some LDTs may not provide accurate test results or perform as well as FDA-authorized tests and others complying with FDA requirements,” according to the agency.
“The FDA is concerned patients could initiate unnecessary treatment, or delay or forego proper treatment altogether, based on inaccurate test results, which could result in harm, including worsening illness or death,” according to the agency.
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The AHA’s side: LDTs are already regulated by other agencies, including the Centers for Medicare and Medicaid Services, and if the FDA were to regulate the tests the same way it regulates medical devices, it would be both time-consuming and very expensive for hospitals, Hughes wrote in the letter.
Labs would be required to submit applications for approval to the FDA for most LDTs. Just one large health system told the AHA it has at least 1,600 LDTs, Hughes wrote, although she did not specify which health system.
The FDA would then review the applications. It takes nearly six months on average for the agency to approve a 510k, the most common type of medical device application, according to 2021 data from quality-management software company Qualio.
“We are concerned that the FDA is not prepared to process this volume of applications in a reasonable timeframe, which would impact access to care for patients,” the AHA letter stated.
Additionally, a 510k application costs $21,760 to submit, according to the FDA.
“Hospitals and health systems simply will not be able to absorb these costs,” the AHA letter stated.
The FDA claimed that its economic analysis “shows that the benefits would outweigh the costs of the rule.”
Ultimately, the proposed FDA rule “could cause patients to lose access to many critical tests and stifle innovative advances in hospitals and health system laboratory medicine,” the AHA claimed. Therefore, FDA oversight of LDTs should only apply to commercial test makers and for-profit labs, the AHA argued.
“The AHA is concerned that the FDA has overreached in its proposal to regulate LDTs as medical devices,” Hughes wrote. “We urge Congress to exempt hospitals and health systems from being included in this FDA device framework or help ensure that regulatory oversight of LDTs is modernized in a manner that both supports medical innovation and ensures that these clinical laboratory tests remain accessible, safe and effective.”