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Food and Drug Act Litigation Products Liability

Exclusion of Evidence: The FDA's 510K Process

In a drug or medical device injury case, one of the defense's most potent arguments often is that the product in question underwent FDA approval. But when a device is approved for sale to the public through the FDA's 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken.

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In a drug or medical device injury case, one of the defense’s most potent arguments often is that the product in question underwent U.S. Food and Drug Administration (FDA) approval, so the balance of its safety and efficacy has already been determined by the federal government to warrant distribution of the product. But when a device is approved for sale to the public through the FDA’s 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken. Still, device makers have shown themselves anxious to present evidence of 510(k) approval to juries considering whether their products are safe for patients to use. Is the fact of 510(k) approval a relevant piece of evidence in this regard?

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