Perfect Defense §510(k) Compliance Win in New Jersey May Be Pyrrhic
Drug & Device Law
JULY 26, 2023
It was thus “unfair for the trial court not to allow [defendant] to explain in response that it received 510(k) clearance to market the devices without clinical studies or trials.” and was approved or licensed. . . This aspect of Hrymoc ignored altogether one of the express statutory terms – “licensed.” Lohr , 518 U.S.
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