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Labs are just beginning to estimate the extent of the operational changes needed to comply with a new federal rule expanding oversight of laboratory tests (LDTs).
In a major shift, most tests designed by individual labs for in-house use must meet Food and Drug Administration requirements for medical devices under a final rule published in May. These requirements, including adverse event reporting, pre-market assessment, registration and labelling, will be phased in over the next four years.
Although the policy aims to improve accuracy and the reliability of LDTs, health industry groups are warning that the regulations will increase costs and administrative burdens, forcing laboratories to scale back the tests they offer. LDTs often fill gaps for clinical needs where commercial tests do not exist, such as in smaller patient populations or those with rare diseases, lab executives say.
“We remain concerned that many essential tests developed in hospitals and health care systems may be subject to unnecessary and costly paperwork,” said Stacey Hughes, executive vice president of government relations and public policy at the American Hospital Association. “This will cause a substantial reduction in patient access to innovative and targeted diagnostic tests.”
Lab organizations are challenge the rule in court. The American Clinical Laboratory Association and the Association for Molecular Pathology sued the FDA for regulatory overreach in a case consolidated in the U.S. District Court for the Eastern District of Texas.
Trade groups argue that LDTs are already regulated The Centers for Medicare and Medicaid Services’ Clinical Laboratory Improvement Amendments (CLIA) program, which duplicates the FDA’s rule.
However, the FDA maintains that the two regulatory regimes are complementary: CLIA oversees laboratory activities, while the FDA regulates separate, critical activities related to the tests themselves, such as design, development, and manufacturing. The agency says more research is needed because the risks associated with LDTs have increased as the tests have become more complex.
Now that the final rule is in effect, laboratories are not waiting for a legal resolution before planning for compliance.
At Yale School of Medicine, it’s “all hands on deck” in the laboratory medicine department as members prepare to meet new FDA requirements, said Alexa Siddon, director of the molecular diagnostics and flow cytometry laboratories.
“We try to provide patients with timely care and personalized care, and so this ruling is quite frightening for us,” Siddon said. “We want to be as prepared as possible and stay on top of things so that we do not experience any delays in patient care.”
Labs are still waiting for more guidance from the FDA on implementing the rule, Siddon said. Staffing to handle the additional workload is another challenge laboratories face.
“We don’t fully know the extent of it yet, but we will first need experts on what the FDA is looking for to help streamline our submissions to the FDA,” Siddon said. There will be a cost for each test submitted, Siddon noted, and staff will be needed to record the tests.
The FDA is conducting a series of webinars and plans to issue more guidance documents on specific topics to help laboratories understand and comply with them with the new regulations, an agency spokesperson said in an emailed statement.
Siddon said the FDA may also need to hire additional people to regulate all labs, “so that we may be competing for the same pool of potential candidates.”
Adam Schechter, CEO of medical testing giant Labcorp, called out the potential disruption to patient care during an earnings call in August: “The question is whether the FDA will even be able to approve these quickly enough so that all patients have access to these tests . important tests as soon as possible?”
As labs grapple with uncertainties surrounding the rule’s impact, lab executives shared their advice for establishing procedures to meet the agency’s timelines in interviews with MedTech Dive.
Here are five steps labs can take now to prepare for the FDA guidance:
1. Create a system for complaints or side effects
The final rule phases out FDA’s previous “enforcement discretion” approach to LDTs in five phases over four years. Phase 1, which begins on May 6, 2025, will require compliance with medical device reporting, corrections and deletions reporting, and complaint file maintenance.
Clinical labs are trying to figure out which scenarios will require a recall, correction or removal of a product from the market as the initial deadline quickly approaches, said Jonathan Genzen, chief medical officer at ARUP Laboratories at the University of Utah. “The boundaries feel very vague to me right now, and I think there is room for better clarification on what is and is not expected,” Genzen said.
Labs will be required to report to the FDA under the manufacturer pathway, which differs from adverse event reporting responsibilities associated with accreditation programs.
“We need to learn as a community how to conduct the review process the way the FDA expects it to be done so that we are okay in future audits,” Genzen said.
Still, Genzen called Phase 1 the “least burdensome” of the five phases because it only applies when a problem is identified and does not affect all testing in a lab.
2. Prepare now for future phases
Phase 2 introduces registration and listing, labeling and research use requirements. The requirements will come into effect from May 2026.
Collecting this data will likely entail a greater burden than Phase 1, Genzen said.
“It will be a big boost for many organizations, especially those that happen to have a lot of LDTs, and the FDA has not provided clarity on how that information should be provided,” Genzen said.
Still unknown, for example, is what type of system is expected to be used, or how device identifiers included in other labeling applications relate to LDTs. Registration costs also play a role, according to Genzen, and some labs may decide they don’t have enough staff to further develop a test.
“That could be a phase in which some laboratories decide to withdraw a test from the market,” Genzen said.
3. Avoid reworking LDTs during development
Much of the research that laboratories are doing now to develop LDTs will be subject to FDA requirements that will apply in three to four years. Phase 3 will see the implementation of quality system procedures, which should take place in May 2027. The FDA will expect compliance with premarket review activities for high-risk LDTs in Phase 4 beginning in November 2027, and moderate- and low-risk LDTs in Phase 5 beginning in May 2028.
“If we ignore it now and say, well, that’s the case in the future, then we’re going to end up doing a lot of rework,” said Stephen Master, chief of laboratory medicine at Children’s Hospital of Philadelphia.
The FDA’s approach to design control in the validation process differs greatly from the framework that laboratories are accustomed to under CLIA regulations, Master said.
“Figuring out how to comply and developing the infrastructure for compliance is truly one of the biggest challenges labs face today,” Master said.
4. Call in the experts
A submission to the FDA requires a significant amount of additional documentation and monitoring, says Inga Rose, CEO of Reference Medicine, a specimen procurement center for oncology diagnostic developers.
Ensuring FDA compliance means building a team that includes both full-time employees and consultants with experience in key areas, Rose said.
Labs need people with knowledge of pre-market approval and 510(k) submissions and a quality team separate from a CLIA team. Statisticians, process engineers, and experts in software validation, bioinformatics, and laboratory operations provide other specialized skills.
“Labs need to be willing to bring in outside consultants in these different areas,” says Rose.
ARUP Laboratories’ Genzen recommended that lab directors meet early with their corporate compliance colleagues to determine who will ultimately manage the process. “You really want to find that out in advance, before you do a lot of preparatory work,” Genzen emphasizes.
5. Be aware of exemptions
Under the new framework, LDTs that are already on the market or designed to address unmet needs will remain under the FDA’s enforcement discretion approach.
The FDA’s decision to exercise limited enforcement authority over currently marketed LDTs “correctly recognized that applying the full scope of its device regulations to these tests would likely cause many hospital laboratories, especially small ones, would stop providing the safe and effective tests that patients and their communities rely on,” said the AHA’s Hughes.
“The enforcement discretion in this final rule is of particular importance,” Hughes said. “We also welcome the agency’s attention to the gaps in FDA-approved, commercially available tests in meeting certain patient needs, such as for rare diseases or conditions.”
LDTs approved by the New York State Department of Health’s Clinical Laboratory Evaluation Program are also excluded from the FDA’s premarket evaluation requirements.
For early-stage companies that don’t have the resources to dedicate themselves to the FDA’s authorization process, “it’s going to hurt them,” said Reference Medicine’s Rose. “Great ideas for new treatments may come from new PhDs coming out of universities, but it can seem insurmountable for them to go through this whole process.”
Carve-outs for small and start-up labs can help, as can planned discounts on registration and submission fees, Rose said.
“I think we’ll see different considerations on that as we get more guidance,” Rose added. “How this will all work remains to be figured out.”