FDA challenged on LDT regulation

Rep. Michael Burgess (R-Texas) challenged FDA's statutory jurisdiction to regulate laboratory developed tests (LDTs) at a hearing of the House Energy and Commerce Subcommittee on Health, and alluded to a longer road ahead.

In late July, FDA released a version of a draft guidance in a notice to Congress, officially marking the agency's plans for a risk-based framework for regulating LDTs (see BioCentury, Aug. 11). ...