You may have heard that the House has asked FDA to suspend its plans to regulates.
In a word, yes.
Find the House subcommittee on Agriculture and FDA here. It released its budget plan, and commentary, for FY2025. Find the 166 page document here.
Scroll up to page 84-85.
Laboratory Developed Tests.—The FDA’s final rule on Laboratory Developed Tests (LDTs) puts forth a proposed regulatory framework that is a significant shift in the way LDTs are regulated and changes expectations for patients, doctors, and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988 at the risk of greatly altering the United States’ laboratory testing infrastructure and reducing patient access to information that informs their healthcare decision making. The Committee directs the FDA to suspend its efforts to implement the rule and continue working with Congress to modernize the regulatory approach for LDTs.
Which means...
The language is "report language," which isn't binding. (If they wanted it to be binding, they'd pass a law telling FDA to suspend.) And it's not final - actual budgets go through months of revision and pass Senate, House, and go to the President at the end.
##
Coverage at HealthCareDive here.
For an article at MedTechDive on how the FDA LDT law may be an early major case for a post-Chevron judicial system - here.
