FDA rescinds LDT final rule

Original from: MEDTECHDIVE

The Food and Drug Administration has rescinded its final rule on laboratory developed tests, formally ending a decades-long effort to expand oversight of the lab industry.

The FDA issued a new final rule, scheduled for publication Friday in the federal register, that changes the definition of in vitro diagnostics back to language that was in its regulations before the 2024 rule was enacted.

The amendment follows a federal district court order in March that vacated the controversial 2024 rule after lab industry groups sued to stop its implementation. The FDA declined to appeal the district court’s ruling. 

With the now-revoked rule, the FDA had sought to bring LDTs, a category of tests created and used within a single lab, under the same regulatory framework as medical devices and other in vitro diagnostics.

LDTs are currently regulated by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments, with the FDA having enforcement discretion.

“The return to enforcement discretion for LDTs rightly recognizes that applying the device regulations to these tests would likely prompt many hospital laboratories, particularly small ones, to stop offering safe and effective tests upon which patients and their communities rely,” the American Hospital Association’s Roslyne Schulman said Thursday in a statement.

“This action will help to assure patient access to innovative and targeted diagnostic tests while reducing regulatory burden and costs for both hospitals and the federal government,” said Schulman, the AHA’s director of outpatient payment, emergency readiness and public health policy.

The FDA estimated the LDT rule would have cost between $1.29 billion and $1.37 billion annually over 20 years.

Source: FDA rescinds LDT final rule