House report asks FDA not to finalize guidance on LDT regulation

In its FY18 budget report, the U.S. House Appropriations Committee called on FDA to halt work to finalize 2014 draft guidance setting out a regulatory framework for laboratory-developed tests (LDTs). The committee said FDA should work with Congress “in a transparent manner” to come up with a new regulatory process.

Since the Clinical Laboratory Improvement Amendments (CLIA) of 1988, CMS has overseen the accreditation, inspection and certification process for laboratories, but has not evaluated LDT validation or clinical validity prior to marketing. The 2014 guidance would have FDA phase in enforcement of risk-based premarket review requirements for LDTs over a nine-year period (see BioCentury, Aug. 11, 2014)...