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Medical Devices

Public Workshop - Regulatory Science Considerations for Software Used in Diabetes Management, November 13, 2014

The Food and Drug Administration (FDA) announced the following workshop entitled:  “Regulatory Science Considerations for Software Used in Diabetes Management.”  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

This workshop was held November 13, 2014 from 8 a.m. to 5 p.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Webcast

Transcript

Agenda

TimeAgenda Item
8:00-8:15 AMWelcome 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 AMIntroduction 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 AMFDA 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 AMNeed for Interoperability of Diabetes Devices
Mr. Howard Look, Tidepool
9:15-9:45 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 Toronto
9:45-10:00 AMQ & A
10:00-10:15 AMBreak
Topic 2: Insulin Bolus Calculators –Basics and Use
10:15-10:35 AMWhat does FDA do?
Dr. James Mullally, Scientific Reviewer, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device and Radiological Health
10:35 -11:05 AMManufacturer’s responsibility in implementing insulin calculators
Dr. Steve Scott, Divisional Vice President, Research and Development, Abbott Diabetes Care
11:05 -11:35 PMClinical aspect and how patients use IBCs
Mr. Adam Brown, diaTribe
11:35-12:50 PMLunch on your own
Topic 3: Insulin Bolus Calculators –Benefits and Risks
12:50-1:00 PMWelcome Back /Announcements
Dr. Runa Musib, Scientific Reviewer, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device and Radiological Health
1:00-1:30 PMClinical Validity of IBCs
Dr. Howard Wolpert, Senior Physician, Joslin Diabetes Center
1:30- 2:00 PMEducating patients on the use of IBCs
Dr. Jane Seley, Diabetes Nurse Practitioner, New York Presbyterian Hospital
2:00-2:45 PMPublic Comment Session
Moderator: Dr. Jacquline Yancy
2:45-3:00 PMBreak
Discussion
3:00-4:00 PMIBC Panel Discussion
Moderator: Dr. David Klonoff, Medical Director, Diabetes Research Institute Mills-Peninsula Health Services
Summary
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

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration,  please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.

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, MD  20993, Tel:  (240) 402-5021/ 301-796-7014, Email: James.Mullally@fda.hhs.gov; runa.musib@fda.hhs.gov

Page Last Updated: 01/12/2016
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