Medtronic Cites FDAMA Clause In Late Hour Bid To Stop IPG Reclassification
This article was originally published in The Gray Sheet
Executive Summary
FDA cannot retroactively apply Sec. 216 of the FDA Modernization Act and use data contained in a Medtronic Itrel premarket approval application in reclassifying implantable pulse generator for use in treating chronic intractable pain, Medtronic says.