FDA Workshop Videos

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