New House bill seeks overhaul of laboratory developed test regulation

By Laura DiAngelo, MPH

A bill introduced in the House would overhaul the regulatory framework for laboratory developed tests, seeking to draw clearer lines between FDA and CMS oversight while establishing a new structure for test validation, performance and reporting.

The proposal would formally codify CMS as the primary regulator of LDTs under CLIA, explicitly carve LDTs out of the FDA’s medical device framework and create new expectations around analytical validity, clinical validity, public test listings and error reporting. FDA would have a new, narrow role in LDT oversight, serving as a third-party assessor under a supplemental affirmation pathway for certain tests.

This AgencyIQ analysis examines how the bill would reshape the diagnostics policy landscape and what the proposed framework could mean for diagnostics developers, the companion diagnostics landscape, drug developers other stakeholders navigating LDT oversight.

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