FDA's LDT Overhaul Should Go Back To Congress, Appropriations Report Says

A fiscal 2025 report from the US House Appropriations Committee instructs the FDA to halt implementation of its overhaul of LDT regulation. Members also showed concern about overseas device manufacturing and the availability of over-the-counter diagnostics.

Image of Congress in the foreground with $100 bills raining in the background — • Source: Alamy

Legislators instructed the US Food and Drug Administration to “suspend” implementation of the final rule on lab-developed tests in the FDA funding bill for fiscal 2025, which passed out of the House Appropriations Committee on 10 July.

In a report attached to the House Appropriations Agriculture, Rural Development, FDA and Related Agencies fiscal year 2025...