FDA Rolls Back Lab Test Regulations After Court Vacatur
Published Date: 9/19/2025
Rule
Summary
The FDA is rolling back a recent rule about lab tests done in labs, called Laboratory Developed Tests (LDTs), because a court said so. This means the rules go back to how they were before May 2024. Labs and medical device makers should keep doing what they were doing before, with no new costs or changes for now.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Court vacates May 6, 2024 LDT rule
If you run a lab or make laboratory-developed tests (LDTs), a court vacated the FDA's May 6, 2024 amendment on March 31, 2025. The FDA has reverted the regulation text to how it existed before the May 2024 final rule.
No new costs or changes for now
If you operate a lab or manufacture LDTs, you should continue following the pre-May 2024 rules and expect no new costs or changes for now, per the FDA's implementation of the March 31, 2025 vacatur.
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