Eastern District of Texas strikes down Food and Drug Administration’s final rule regulating laboratory developed tests

From the article:

In the never-ending saga over the battle to regulate laboratory-developed tests (LDTs), the Eastern District of Texas took the wind out of FDA’s sails on Monday, vacating FDA’s Final Rule that intended to regulate LDTs as medical devices similar to in vitro diagnostic (IVD) tests, which are commercially manufactured and undergo pre-market review by FDA.1 Clinical laboratories can halt their plans, for now, to comply with the Final Rule’s May 6, 2025, deadline to implement certain features of FDA’s medical device quality system regulations.

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Clinical laboratories will see the ruling as a major victory for the laboratory industry. The district court’s ruling also comes as one of the first major checks on FDA’s power in the post-Chevron world following last year’s Supreme Court decision in Loper Bright.

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Explaining the storied history of LDT regulation, the district court found no question that Congress had considered the unique regulatory issues raised by clinical laboratories and the tests that they develop and perform, and that Congress chose to regulate these tests as “services” under CLIA. This contrasts with the authority Congress granted FDA to regulate “devices,” which the district court concluded under the FDCA to mean “articles in commerce,” not “services” performed by doctors and laboratories.

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While it is possible that FDA could appeal the decision, we do not expect the current Administration to do so. Experts had already predicted that President Trump was likely to order FDA to repeal, or not enforce, the Final Rule, as HHS under the first Trump Administration had revoked FDA’s guidance document claiming authority to regulate LDTs as devices.

It's odd that there are no mainstream newspapers covering this. I guess lab tests are too niche?