US Spending Bill Rider Looks To Stop Already Halted FDA LDT Guidance

A US FDA spending bill approved by the House Appropriations Committee July 12 would halt finalization of the agency's draft 2014 laboratory developed test guidance, recommending that FDA let Congress write its own bill directing any LDT regulation – but FDA already essentially handed the LDT reins to lawmakers last January.

House appropriators, as expected, have added a rider to 2018 FDA funding legislation directing that the agency suspend any efforts to finalize its laboratory-developed test guidance proposed Oct. 3, 2014 – but the agency already completely stopped work on its LDT guidance activities in January. (Also see "House Appropriators Will Tell US FDA 'Don't Finalize' LDT Guidance In 2018 Funding Bill" - Medtech Insight, 29 June, 2017.)

The Appropriations Committee passed an Agriculture/FDA funding bill July 12 that would give FDA a total of $2.8bn in discretionary...

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