FDA Effectively Scraps LDT Rule By Not Appealing Court Ruling

By Maaisha Osman / June 2, 2025 at 5:09 PM

FDA’s decision not to appeal a federal court ruling that invalidated its attempt to regulate laboratory-developed tests (LDTs) under the medical device framework signals the Trump administration’s intention not to defend the rule -- a move that falls in line with the previous Trump administration’s move to block FDA from regulating LDTs.


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