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.
We are writing to request that the Food and Drug Administration (FDA) withdraw the proposed draft guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests” and associated guidance. The draft guidance documents conflict with existing regulations and would impose substantial new…
We support FDA’s efforts to improve the safety and efficacy of POC BGMS used for hospitalized patients. However, we are concerned that, as written, the draft guidance would have serious unintended consequences for patients and hospitals, including placing patients at unnecessary risk.