Laboratory Developed Tests (LDTs)
Many hospitals and health care systems develop and use LDTs, particularly larger hospitals, including academic medical centers. LDTs are diagnostic tests that are not commercially distributed to other laboratories but, instead, are developed, validated and performed in-house by individual laboratories. They range from routine tests such as blood counts to more complex molecular and genetic tests for cancer, heart disease, and rare and infectious diseases. LDTs are critical in providing timely patient access to accurate and high-quality testing for many conditions for which no commercial tests exist or where an existing test does not meet current clinical needs. They also provide physicians with important clinical information to diagnose and treat patients and are essential to the practice of all areas of medicine. Indeed, these tests are typically developed at the request of, and in close collaboration with, clinical caregivers.
The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules to laboratory-developed tests. The final rule is in response to a March 31 federal district court decision that also vacated the FDA’s 2024 final rule.
The AHA appreciates that the FDA and the federal district court have acknowledged the unique value and safety of laboratory tests developed by hospitals and health systems for direct use in patient care.
A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its final rule to regulate laboratory-developed tests as medical devices, effectively eliminating it. The rule, issued last year, would have phased out its general enforcement…
The U.S. District Court for the Eastern District of Texas March 31 ruled that the Food and Drug Administration does not have the authority to regulate laboratory-developed tests.
One trend CB Insights analysts are watching is how AI is helping patients engage with health systems before the diagnostic process begins and to flag diseases earlier.
The Food and Drug Administration (FDA) on April 29 issued a final rule that will phase out, over four years, its general enforcement discretion approach for in vitro diagnostic tests (IVDs), which include laboratory developed tests (LDTs).
The Food and Drug Administration April 29 issued a final rule that would phase out its general enforcement discretion approach for most laboratory developed tests over four years, citing concern that some of the tests may not provide accurate results or perform as well as FDA-approved in vitro…
The Food and Drug Administration’s proposal to regulate laboratory developed tests would undermine innovation and reduce access to effective and appropriate care for patients, AHA April 1 told the Senate Health, Education, Labor & Pensions Committee Ranking Member.
The Food and Drug Administration’s proposal to regulate laboratory developed tests would undermine innovation and reduce access to effective and appropriate care for patients, AHA March 21 told the House Energy and Commerce Subcommittee on Health.
AHA statement before the House Committee on Energy and Commerce
Subcommittee on Health on the impact of the Food and Drug Administration’s (FDA) proposed regulation of diagnostic tests.