New House bill seeks overhaul of laboratory developed test regulation

By Laura DiAngelo, MPH

A new House bill 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 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. It would also give the FDA a narrower, voluntary third-party role through 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 laboratories, test developers, companion diagnostics and other stakeholders navigating LDT oversight.

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