What the FDA's Final Rule Means for the Future of Laboratory Developed Tests

In early May, the U.S. FDA issued their long-awaited, groundbreaking Final Rule governing the oversight of laboratory developed tests (LDTs). This new rule will dramatically alter the LDT regulatory landscape, while at the same time requiring monumental operational changes and increased costs for LDT manufacturers, laboratories, and academic medical centers. The ruling will seek to phase out the current enforcement discretion approach for LDTs and instead reclassify these tests as in vitro diag

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