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Unlocking Legalities: To Change How Courts View 510(k) Clearances, Industry Seeks 'Supreme' Support

Executive Summary

Medtech's legal realm wants the US Supreme Court to correct the record on 510(k)s next term, and they say they've found the right case to make that happen: a J&J/Ethicon mesh device suit where the lower court refused to let the jury hear any mention at all of US FDA or the product's 510(k) clearance. Courts say 510(k)s lack sufficient relevance to support a company's case for product safety, but industry says that view is based on outdated facts and is fundamentally unfair.

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