Remove 2015 Remove FDA Compliance Remove Licensing
article thumbnail

Perfect Defense §510(k) Compliance Win in New Jersey May Be Pyrrhic

Drug & Device Law

In these states, product liability claims are brought as negligence actions based on the reasonableness of a defendant’s conduct, and a defendant’s compliance with applicable governmental standards is typically relevant evidence. 2015 WL 5567578, at *6-7 (W.D.N.C. and was approved or licensed. . . See Winebarger v. device. . .