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Advertisement New Jersey Appellate Division Finds that Evidence of 510(k) Clearance Cannot be Categorically Excluded in Medical Device Product Liability Cases Wednesday, April 21, 2021 FDA clears the vast majority of medical devices for marketing through the 510(k) process. In product liability cases involving 510(k) medical devices, plaintiffs often seek to exclude 510(k) evidence from trial based on arguments that: (1) the 510(k) process is less rigorous than the pre-market approval (PMA) process, and does not include the FDA’s independent evaluation of safety and efficacy; (2) the jury may place undue emphasis on the FDA’s 510(k) clearance; and (3) admission of the evidence leads to mini-trials on the meaning and significance of the 510(k) clearance. Device manufacturers typically oppose the exclusion of 510(k) evidence because it unfairly prevents them from explaining to the jury the regulatory requirements and framework that dictate their decision making. In a p

New jerseyUnited statesBergen countyNorth carolinaEthicon proliftEthicon incAppellate division decisionAppellate divisionTrial court proceedingsJersey superior courtJersey appellate divisionNew jersey appellate divisionNew jersey product liability actNew jersey superior courtபுதியது ஜெர்சிஒன்றுபட்டது மாநிலங்களில்