Tag: LDT Regulations 2 results

MedTech

Is Your Lab Ready? Complying with FDA’s Final Rule on LDTs, Stage 1

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…