Lifecore Biomedical
This article was originally published in The Gray Sheet
Executive Summary
FDA Medical Devices Dispute Resolution Panel (MDDRP) review will be sought following device center's "not approvable" determination for Lifecore's Gynecare Intergel ferric hyaluronate adhesion prevention solution. The firm had submitted an amendment to its March 1999 premarket approval application in June 2000, following a recommendation against approval from FDA's General and Plastic Surgery Devices Advisory Panel last January (1"The Gray Sheet" Jan. 17, 2000, p. 4). The MDDRP, mandated by the FDA Modernization Act of 1997, had its inaugural meeting Oct. 31, 2000 (2"The Gray Sheet" Nov. 6, 2000, In Brief)