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Laboratory developed test: Revision history


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  • curprev 01:2301:23, 15 December 2022 SteveChervitzTrutane talk contribs 3,916 bytes +15 United States: Updated citation and provided archive link for CAP's LDT FAQ - original PDF is now 404. Previous citation consisted of just the URL + excerpt: "Current oversight requirements governing LDTs are the laboratory requirements prescribed in CLIA. The FDA claims jurisdiction for the oversight of LDTs and exercises an enforcement discretion policy at this time. The FDA has not finalized a plan to regulate LDTs but defers to Congress to draft legislation to address this issue" undo

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