FzioMed Inc.

A June 10 Medical Devices Dispute Resolution Panel for FzioMed Inc. ’s Oxiplex spine surgery gel will be postponed to give FDA’s device center time to consider whether new data from the company c

FzioMed Dispute Panel FDA has officially scheduled the first meeting of its Medical Devices Dispute Resolution Panel in more than seven years for June 10. The meeting will address the agency’s prior d

Guidance on 510(k)s for human leukocyte antigen test kits Labeling for nucleic-acid-based human leukocyte antigen (HLA) test kits should specify the marker the test is intended to detect, and performa

FDA’s Medical Devices Dispute Resolution Panel will meet for the first time since 2007 to discuss FzioMed Inc. ’s Oxiplex gel, which FDA previously deemed “not approvable” following an unfavorabl