On May 6, 2024, the US Food and Drug Administration (FDA) finalized a new rule to regulate laboratory-developed tests (LDTs). FDA’s New RuleThe FDA’s new rule will place LDTs in a category under FDA oversight. ImplicationsThe FDA rule carries considerable benefits. Although regulating LDTs as devices risks importing these problems, given current congressional gridlock, the FDA rule constitutes a clever approach in a difficult climate. However, the FDA’s decision to exempt preexisting LDTs from key parts of the rule may blunt the overall public health impact.

Source: New York Times October 11, 2024 16:09 UTC