Remove FDA Remove FDA Compliance Remove Licensing
article thumbnail

Perfect Defense ยง510(k) Compliance Win in New Jersey May Be Pyrrhic

Drug & Device Law

So plaintiffs will not be able to hide the truth of FDA regulation from the jury on retrial, while misleading the jury, nor try the same trick in any other pelvic mesh case in New Jersey going forward. and was approved or licensed. . . This aspect of Hrymoc ignored altogether one of the express statutory terms โ€“ โ€œlicensed.โ€