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Laboratories are just beginning to assess the extent of operational changes required to comply with a new federal rule that expands regulatory oversight of laboratory-developed tests (LDTs).

In a major change, most tests designed by individual laboratories for in-house use must meet the Food and Drug Administration’s requirements for medical devices under a final rule published in May. These requirements, including adverse event reporting, pre-market review, registration and labeling, will be phased in over the next four years.

Although politics aims to improve accuracy and reliability of LDTs, health industry groups warn that the regulations will add costs and administrative burdens that will force labs to reduce the tests they offer. LDTs often fill gaps for clinical needs where there are no commercial tests, such as smaller patient populations or people with rare diseases, lab directors say.

“We remain concerned that many vital tests developed in hospitals and health systems may be subject to unnecessary and costly paperwork,” said Stacey Hughes, executive vice president for government relations and public policy at the American Hospital Association. “This will result in a substantial reduction in patient access to innovative and targeted diagnostic tests.”

Laboratory organizations are challenging the rule in court. The American Association of Clinical Laboratories and the Association for Molecular Pathology sued the FDA, alleging regulatory overreach, in a case that was consolidated in the United States District Court for the Eastern District of Texas.

Trade groups argue that LDTs ​​are already regulated under Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) program, which makes the FDA rule duplicative.

FDA maintains, however, that the two regulatory schemes are complementary: CLIA oversees laboratory operations, while FDA regulates separate, critical activities involving the tests themselves, such as design, development, and manufacturing. The agency says greater scrutiny is needed because the risks associated with LDTs ​​have increased as the tests have become more complex.

With the final rule now in place, laboratories are not waiting for a legal resolution before planning for compliance.

At Yale School of Medicine, “all hands are 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’re trying to provide timely care and personalized care to patients, so this decision is pretty scary for us,” Siddon said. “We want to be as prepared as we can and stay ahead of the curve so we don’t have any drop in patient care.”

Labs are still waiting for more guidance from the FDA on how to implement the rule, Siddon said. Another challenge labs face is staffing to handle the additional workload.

“We don’t know the full extent of it yet, but we will first need experts in what the FDA is looking for to help streamline our submissions to the FDA,” Siddon said. Each test sent will have an associated cost, Siddon noted, and staff will be required to record the tests.

The FDA performs a webinar series and plans to issue more guidance documents on specific topics to help laboratories understand and comply with the new regulations, an agency spokesman said in an emailed statement.

Siddon said the FDA may also need to hire additional people to regulate all the labs, “so we could be competing for the same pool of potential applicants.”

Adam Schechter, CEO of medical testing giant Labcorp, announced the potential disruption to patient care in an August earnings call: “The question is whether the FDA will have the ability to approve them quickly enough so that all patients have access to them. important tests as soon as possible?”

As labs grapple with the uncertainties surrounding the impact of the rule, lab directors shared their tips for establishing procedures to meet the agency’s deadlines in interviews with MedTech Dive.

Here are five steps labs can take now to prepare for the FDA directive: