Lifecore Biomedical
This article was originally published in The Gray Sheet
Executive Summary
FDA's Medical Device Dispute Resolution Panel meeting is postponed "to permit the resolution of procedural issues and to provide time to adequately address the scientific issues," Lifecore announces May 30. The panel was set to convene June 4 to review the device center's "not approvable" determination for Lifecore's Gynecare Intergel ferric hyaluronate adhesion prevention solution (1"The Gray Sheet" May 14, 2001, In Brief). Under the timeline laid out in CDRH's 1999 draft guidance, MDDRP meetings should take place within 60 days of a decision to assign an issue to the panel. The panel referral was made in February (2"The Gray Sheet" Feb. 12, 2001, In Brief), which puts the device center behind schedule