FDA’s OIVD Begins Open Dialogue With LabNet Sites
MedSun: Newsletter #13, March 2007
In March 2007, the Office of In Vitro Diagnostic (OIVD) of the Food and Drug Administration (FDA) began its “open dialogue” with LabNet participants by means of telephone calls to seven LabNet sites. Dr. Steve Gutman, Director of OIVD, talked to LabNet participants, most of whom said that they were pleased with LabNet training and that they believe they understand how to report problems. At least one participant indicated a desire for more timely input from manufacturers about newly identified problems. At another site, a reporter mentioned the desire to network with other laboratories in the LabNet subproject. Other subjects that arose during these conversations were human factors concerns with in vitro diagnostic devices (IVDs) and the accuracy of IVDs when used with special patient populations. Dr. Gutman and OIVD staff encouraged LabNet sites to share these and other types of incidents with FDA. Some sites have not yet reported issues, either because products are working well, or because companies, when contacted, have provided satisfactory responses to problems identified. LabNet site representatives seemed pleased with these OIVD outreach efforts, so Dr. Gutman and his staff will contact all participants in the LabNet project over the next several months and then hold followup calls in 6 to 9 months.