Video from FDAs workshop on interoperability and bolus calculators. Held 11/13/14
Webcast Recordings and Presentations posted for the Regulatory Science Considerations for Software Used in Diabetes Management Public Workshop, November 13, 2014
Webcast
Agenda
| 8:00-8:15 AM | Welcome and Announcements Dr. Jacquline Yancy, Scientific Reviewer, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device and Radiological Health |
| 8:15-8:30 AM | Introduction and Purpose of the Meeting Dr. Alberto Gutierrez, Director, Office of In Vitro Diagnostic Device and Radiological Health, CDRH |
| Topic 1: Interoperability and FDA Update | |
| 8:30-8:45 AM | FDA Updates on Diabetes Diagnostic Devices and Diabetes Management Systems Dr. Alain Silk, Scientific Reviewer, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device and Radiological Health |
| 8:45-9:15 AM | Need for Interoperability of Diabetes Devices Mr. Howard Look, Tidepool |
| 9:15-9:45 AM | Current Status of Efforts to Standardize Interoperability of Diabetes Devices Dr. Joe Cafazzo, Associate Professor, Institute of Biomaterials and Biomedical Engineering, Faculty of Medicine, University of Toronto |
| 9:45-10:00 AM | Q & A |
| 10:00-10:15 AM | Break |
| Topic 2: Insulin Bolus Calculators Basics and Use | |
| 10:15-10:35 AM | What does FDA do? Dr. James Mullally, Scientific Reviewer, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device and Radiological Health |
| 10:35 -11:05 AM | Manufacturers responsibility in implementing insulin calculators Dr. Steve Scott, Divisional Vice President, Research and Development, Abbott Diabetes Care |
| 11:05 -11:35 PM | Clinical aspect and how patients use IBCs Mr. Adam Brown, diaTribe |
| 11:35-12:50 PM | Lunch on your own |
| Topic 3: Insulin Bolus Calculators Benefits and Risks | |
| 12:50-1:00 PM | Welcome Back /Announcements Dr. Runa Musib, Scientific Reviewer, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device and Radiological Health |
| 1:00-1:30 PM | Clinical Validity of IBCs Dr. Howard Wolpert, Senior Physician, Joslin Diabetes Center |
| 1:30- 2:00 PM | Educating patients on the use of IBCs Dr. Jane Seley, Diabetes Nurse Practitioner, New York Presbyterian Hospital |
| 2:00-2:45 PM | Public Comment Session Moderator: Dr. Jacquline Yancy |
| 2:45-3:00 PM | Break |
| Discussion | |
| 3:00-4:00 PM | IBC Panel Discussion Moderator: Dr. David Klonoff |
| Summary | |
| 4:00 PM | Wrap-Up and Summary Dr. Courtney Lias, Director, Division of Chemistry and Toxicology devices, Office of In Vitro Diagnostic Device and Radiological Health, CDRH |