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Medical Devices / Research and Development

FY 2018 Appropriations Bill Includes Freeze on FDA Guidance for LDTs

July 18, 2017

In report language accompanying the fiscal 2018 appropriations bill, Congress says it wants the FDA to continue its freeze on finalizing 2014 draft guidance on a regulatory framework for laboratory-developed tests (LDTs).

The 2014 guidance would have seen the agency phase in enforcement of risk-based premarket review requirements for LDTs over a nine-year period. But instead of finalizing the guidance, appropriators want to work with the agency and stakeholders on a statutory solution for regulation of tens of thousands of laboratory-developed tests currently being used across the country.

“The Committee maintains its position that FDA should suspend further efforts to finalize the LDT guidance and continue working with Congress to pass legislation that addresses a new pathway for regulation of LDTs in a transparent manner,” the report says.

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