A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests. The suit, filed in a Texas ...
The U.S. trade group representing laboratory companies and test manufacturers is suing to block the FDA from increasing its oversight of lab-developed tests, saying the agency overstepped its ...
Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory ...
FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland (Reuters) -The U.S. Food and Drug Administration (FDA) on Monday tightened regulations for clinical laboratories with a ...
ARUP Files Declaration to Support Lawsuit Challenging the FDA's Rule to Regulate Lab-Developed Tests
SALT LAKE CITY, June 3, 2024 /PRNewswire/ -- ARUP Laboratories is backing a federal lawsuit filed by the American Clinical Laboratory Association (ACLA) challenging the FDA's final rule to regulate ...
The FDA has opted to not appeal a federal court decision that struck down the agency’s rule to regulate laboratory-developed tests as medical devices. The 60-day window for appeal has passed, ...
On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs).[1] The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for clinical use ...
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