The Food and Drug Administration (FDA) announced the following workshop entitled: “Regulatory Science Considerations for Software Used in Diabetes Management.â€Â The purposes of this workshop were to foster greater stakeholder collaboration in the area of diabetes device interoperability and to seek input form the clinical community, academia, government, industry and other stakeholders regarding the makeup of the intended use population for insulin bolus calculators, and the technical considerations for their design and use.
- Date, Time and Location
- Federal Register Notice
- Webcast
- Agenda
- Registration
- Contact Us
FDA Campus Information
Webcast
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 Health8:45-9:15 AMNeed for Interoperability of Diabetes Devices
Mr. Howard Look, Tidepool9:15-9:45 AMCurrent 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 Toronto9:45-10:00 AMQ A10:00-10:15 AMBreakTopic 2: Insulin Bolus Calculators –Basics and Use10:15-10:35 AMWhat does FDA do?
Dr. James Mullally, Scientific Reviewer, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device and Radiological Health10:35 -11:05 AMManufacturer’s responsibility in implementing insulin calculators
Dr. Steve Scott, Divisional Vice President, Research and Development, Abbott Diabetes Care11:05 -11:35 PMClinical aspect and how patients use IBCs
Mr. Adam Brown, diaTribe11:35-12:50 PMLunch on your ownTopic 3: Insulin Bolus Calculators –Benefits and Risks12:50-1:00 PMWelcome Back /Announcements
Dr. Runa Musib, Scientific Reviewer, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device and Radiological Health1:00-1:30 PMClinical Validity of IBCs
Dr. Howard Wolpert, Senior Physician, Joslin Diabetes Center1:30- 2:00 PMEducating patients on the use of IBCs
Dr. Jane Seley, Diabetes Nurse Practitioner, New York Presbyterian Hospital2:00-2:45 PMPublic Comment Session
Moderator: Dr. Jacquline Yancy2:45-3:00 PMBreakDiscussion 3:00-4:00 PMIBC Panel Discussion
Moderator: Dr. David KlonoffSummary 4:00 PMWrap-Up and Summary
Dr. Courtney Lias, Director, Division of Chemistry and Toxicology devices, Office of In Vitro Diagnostic Device and Radiological Health, CDRH
[email protected] at least 7 days in advance of the meeting.
[email protected].
For questions regarding workshop content please contact James Mullally or Runa Musib, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66 Rm. 5613/5633, Silver Spring, MDÂ 20993, Tel:Â (240) 402-5021/ 301-796-7014, Email:Â [email protected]; [email protected]
Dr. Alain Silk, Scientific Reviewer, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device and Radiological Health8:45-9:15 AMNeed for Interoperability of Diabetes Devices
Mr. Howard Look, Tidepool9:15-9:45 AMCurrent 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 Toronto9:45-10:00 AMQ A10:00-10:15 AMBreakTopic 2: Insulin Bolus Calculators –Basics and Use10:15-10:35 AMWhat does FDA do?
Dr. James Mullally, Scientific Reviewer, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device and Radiological Health10:35 -11:05 AMManufacturer’s responsibility in implementing insulin calculators
Dr. Steve Scott, Divisional Vice President, Research and Development, Abbott Diabetes Care11:05 -11:35 PMClinical aspect and how patients use IBCs
Mr. Adam Brown, diaTribe11:35-12:50 PMLunch on your ownTopic 3: Insulin Bolus Calculators –Benefits and Risks12:50-1:00 PMWelcome Back /Announcements
Dr. Runa Musib, Scientific Reviewer, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device and Radiological Health1:00-1:30 PMClinical Validity of IBCs
Dr. Howard Wolpert, Senior Physician, Joslin Diabetes Center1:30- 2:00 PMEducating patients on the use of IBCs
Dr. Jane Seley, Diabetes Nurse Practitioner, New York Presbyterian Hospital2:00-2:45 PMPublic Comment Session
Moderator: Dr. Jacquline Yancy2:45-3:00 PMBreakDiscussion 3:00-4:00 PMIBC Panel Discussion
Moderator: Dr. David KlonoffSummary 4:00 PMWrap-Up and Summary
Dr. Courtney Lias, Director, Division of Chemistry and Toxicology devices, Office of In Vitro Diagnostic Device and Radiological Health, CDRH
[email protected] at least 7 days in advance of the meeting.
[email protected].
For questions regarding workshop content please contact James Mullally or Runa Musib, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66 Rm. 5613/5633, Silver Spring, MDÂ 20993, Tel:Â (240) 402-5021/ 301-796-7014, Email:Â [email protected]; [email protected]
10903 New Hampshire Ave., Bldg. 66 Rm. 5613/5633, Silver Spring, MDÂ 20993, Tel:Â (240) 402-5021/ 301-796-7014, Email:Â [email protected]; [email protected]