FDA has officially rescinded the LDT regulation which lost in federal court last spring. The main act of recission was brief, merely removing a few words of text from the relevant regulation. However, an appendix on financial costs and benefits annotated the billions of dollars of regulatory costs the move would have required, and the "billions" of dollars of "benefits" (largely speculative and cast in terms of dollarized life-years) the FDA had projected.
The regulatory change is signed by RFK Jr.
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News items:
The rule was dead back around June 1, 2025, when a 60-day deadline to appeal the FDA's loss in court, was let pass.
One of my most fun blogs of the past year was on December 25, 2024, when I fed the final legal arguments of FDA and its opponents into Chat GPT, which took the role of an "AI Judge" and predicted the FDA would lose. Here.
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AI CORNER
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I asked Chat GPT to summarize the FDA's short publication rescinding the rule. FDA makes no editorial comment about LDTs or future actions on LDTs. But, FDA is obligated to publish a couple pages of changed financial projections.
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FDA has formally rescinded its 2024 rule defining laboratory developed tests (LDTs) as medical devices after a federal court vacated the regulation in March 2025. The agency has reverted to the prior definition in 21 CFR 809.3, emphasizing that this action is ministerial and imposes no new compliance obligations.
In its economic analysis, FDA highlights that vacating the rule saves an estimated $1.44–$1.54 billion annually (in 2024 dollars), mostly accruing to U.S. laboratories and suppliers, and is classified as a deregulatory action under Executive Order 14192.
At the same time, FDA notes that the United States forgoes an estimated $3.7–$4.6 billion in annualized public health benefits, primarily from highly speculative “life-years gained” projections.
The agency acknowledges that the uncertainty ranges for benefits and costs are wide enough to overlap, meaning the rule could have produced either net positive or net negative effects. FDA also observes that its quantitative models omit difficult-to-measure factors, such as potential impacts on innovation, underscoring the tentative nature of the original projections.
