A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...
A federal judge in Texas has ruled that the FDA does not have the authority to regulate laboratory developed tests as medical ...
Published in 2024, the FDA’s ‘Final Rule’ outlined plans to subject lab-developed tests to the same requirements as medical ...
The ruling prevents the FDA rule on LDTs, which is opposed by much of the clinical lab industry and many segments of the broader healthcare industry, from going into effect.
HealthTrackRx, alongside the American Clinical Laboratory Association (ACLA), challenged the FDA's rule imposing significant additional regulatory requirements on LDTs. The rule threatened access to ...
A federal judge ruled Monday that the FDA doesn’t have the legal authority to regulate lab-developed tests, dealing a blow to ...
A group of researchers have created four novel laboratory-developed tests that can distinguish between and subclassify atopic ...
This varies according to the laboratory and the location. Though Medicare covers most clinical diagnostic tests, including thyroid tests, a person will generally have some costs, as shown below.
16h
ARUP is grateful to the U.S. District Court in Texas for the careful consideration of this topic and the recognition of the sweeping changes to our ...
The 1950 outdated hospital building got its very long awaited upgrade according to KDHE’s Director of Laboratories Sameer ...
The automated DxC 500 I analyzer has a throughput of up to 800 clinical chemistry tests and 100 immunoassays per hour.
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