Lifecore Biomedical
This article was originally published in The Gray Sheet
Executive Summary
FDA's Medical Device Dispute Resolution Panel will convene June 4 to review the device center's "not approvable" determination for Lifecore's Gynecare Intergel ferric hyaluronate adhesion prevention solution. Comments or requests for time to make oral presentations should be submitted to ombudsman Les Weinstein by May 31. Background information and questions for the committee will be posted June 1 at http://www.fda.gov/cdrh/panelmtg.html. The review will be the first to occur since the MDDRP was mandated by the FDA Modernization Act of 1997 (1"The Gray Sheet" Jan. 1, 2001, In Brief)