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BioWorld - Tuesday, November 11, 2025
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Home » Bard loses appeal of US lawsuit after judge in jury trial disallows evidence of 510(k)
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Bard loses appeal of US lawsuit after judge in jury trial disallows evidence of 510(k)

Aug. 21, 2023
By Mark McCarty
U.S. federal preemption of state liability law for medical devices is firmly established for PMA devices, but this is not the case for devices that are cleared via the U.S. FDA‘s 510(k) program. However, some courts have gone a step further in disallowing defendants in product liability litigation from entering evidence of 510(k) clearances from the FDA, a practice that played a role in a $3.3 million verdict against Murray Hill, N.J.-based C.R. Bard Inc. that the U.S. Court of Appeals for the Seventh Circuit decreed is not eligible for a new trial.
BioWorld MedTech Regulatory U.S. FDA

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