Dispute resolution
This article was originally published in The Gray Sheet
Executive Summary
Third parties wishing to give oral presentations at the Sept. 6 Medical Device Dispute Resolution Panel should contact Les Weinstein, CDRH ombudsman, before Sept. 4. The MDDRP, the first under the FDAMA-mandated dispute resolution provision, will review the "non-approvable" determination for Lifecore's Gynecare Intergel adhesion prevention solution