A rider "that prevents FDA from finalizing guidance on laboratory-developed tests" will appear in report language for the House's FY 2018 FDA appropriations bill, Rep. Rosa DeLauro, D-Conn., said at a June 28 House Appropriations Committee, Agriculture and FDA subpanel markup. The rider follows FDA's decision in January to put off long-held plans to finalize a regulatory framework guidance for LDTs, leaving it up to Congress to figure out the best regulatory pathway for the diagnostic services.
DeLauro said she has "concerns" about the report language, which from her perspective, leaves LDTs "unregulated."