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)
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Lifecore Biomedical
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 Under the timeline laid out in CDRH's 1999 draft guidance, MDDRP meetings should take place within 60 days of a decision to assign an issue to the panel.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
Lifecore Biomedical
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 Under the timeline laid out in CDRH's 1999 draft guidance, MDDRP meetings should take place within 60 days of a decision to assign an issue to the panel.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
Lifecore Biomedical
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)