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BioWorld - Thursday, May 21, 2026
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Home » US House committee recommends FDA move on rulemaking for LDT regulation
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US House committee recommends FDA move on rulemaking for LDT regulation

June 14, 2023
By Mark McCarty
The June 14 hearing of the House Appropriations Committee was focused largely on spending levels for the Department of Agriculture, but there was also some concern over the proposed spending levels for the FDA. One of the more conspicuous features of the legislative report is the recommendation that the FDA finalize guidance or rulemaking for risk-based regulation of lab-developed tests (LDTs), a clear departure from the stance taken by Congress for a number of years.
BioWorld Medical technology Regulatory Diagnostics U.S. FDA

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