Perfect Defense §510(k) Compliance Win in New Jersey May Be Pyrrhic
Drug & Device Law
JULY 26, 2023
470 (1996), outside of the (now obsolete) presumption against preemption context in which it occurred − making FDA compliance an all-or-nothing proposition in medical device cases. 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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