For decades, laboratory developed tests (LDTs) have operated under minimal FDA oversight, but advancements in molecular biology, the rise of personalized medicine, and the critical role of diagnostic testing have prompted the FDA to revise its approach. In its recently announced phaseout policy, the FDA is moving toward full regulatory control of LDTs. By February…
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Laboratory-developed tests (LDTs) have played a critical role in healthcare for decades, providing clinicians with diagnostic insights tailored to specific patient needs. Historically, these tests, developed and used within individual laboratories, have operated under the oversight of the Centers for Medicare and Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA). The FDA, though…