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Home » New Jersey court reverses lower court’s decree that issuance of 510(k) is inadmissible in trial
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New Jersey court reverses lower court’s decree that issuance of 510(k) is inadmissible in trial

April 27, 2021
By Mark McCarty
The FDA’s premarket review mechanisms for class II medical devices may strike some as little more than so much regulatory esoterica, and several courts have ruled that information about the 510(k) process is inadmissible during jury trials due to the possibility of sowing confusion among jurors. An appellate court in New Jersey has ruled that such an exclusion of evidence is prejudicial in a case involving surgical mesh manufactured by two device companies, however, opening a larger debate about the propriety of such exclusions in product liability litigation for medical devices.
BioWorld MedTech Regulatory Surgical mesh U.S. 510(k) Courts FDA

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