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Home 5 Lab Industry Advisor 5 National Lab Reporter 5 CLIA-nir 5 LDT Oversight Remains Under CLIA, for Now

LDT Oversight Remains Under CLIA, for Now

by | Apr 4, 2025 | CLIA-nir, CMS-nir, Compliance-nir, Enforcement-nir, Essential, FDA-lca, FDA-lir, FDA-nir, Lab Industry Advisor, LDTs-lir

Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests

In the latest twist on LDT oversight, a judge vacated the FDA’s LDT rule
G2 Intelligence screenshot

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