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Changes are Coming: What You Need to Know About Laboratory Developed Tests

The Food and Drug Administration (FDA) is about to make a change when it comes to how Laboratory Developed Tests (LDTs) are regulated, and its proposed overhaul of the current system is making waves within the scientific community. On October 3, 2014, the FDA publicly released a 41-page document titled “Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).” Then, in December 2015, the FDA released a set of 20 case studies providing public health evidence in support of its proposed oversight. While the new regulations are currently being finalized, some organizations have spoken out in opposition to the changes. Let’s take a look at both sides of the story.

The old

Today, clinical laboratories are regulated by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA), a set of regulations last revised in 1988 that remain the primary mechanism for oversight. CLIA regulations cover standards in personnel performance, test performance and provide for on-sight inspections. In recent years, however, many in the in vitro diagnostics (IVD) industry and general scientific community have called for additional oversight of LDTs than what is currently provided by CLIA. This belief is at the root of the FDA’s 2014 draft guidance release: CLIA needn’t be replaced, but additional measures need to be taken in the interest of public health.