Washington – A Federal Judge of Texas crushed the plan of Food and Drug Administration to regulate the tests developed in the laboratory on Monday, under the laboratory commercial groups which declared that the agency exceeded its limits.
“The court leaves and puts aside, in its entirety, the final rule of the FDA entitled Medical Devices; Laboratory has developed tests, ”says the decision. “The court refers this case to the secretary of health and social services for a more in -depth examination.”
The FDA has always believed the power to regulate the tests developed in the laboratory as a medical devices, but it did not exercise this authority historically. It was only under President Biden that the agency announced its intention to actively regulate the tests, giving laboratories until 2028 to comply. This decision reached after the congress attempted and did not give the FDA a more explicit authority in 2022.
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