39
References
1. U.S. Food and Drug Administration. Draft Guidance for Industry
and Staff. Total Product Life Cycle for Portable Invasive Blood
Glucose Monitoring System. [Electronic Version]. Retrieved July
6, 2009 from
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm079138.htm .
2. Larsson-Cohn U: Difference between capillary and venous blood
glucose during oral glucose tolerance tests. Scand J Clin Lab
Invest 36:805-808, 1976.
3. U.S. Food and Drug Administration. Blood Glucose Meters,
Getting the Most Out of Your Meter. [Electronic Version].
Retrieved December 22, 2009 from
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
TipsandArticlesonDeviceSafety/ucm109371.htm .
4. Data on file.
5. International Organization for Standardization. In vitro diagnostic test
systems. Requirements for blood-glucose monitoring system for self-
testing in managing diabetes mellitus. Reference number ISO
15197:2003 (E). Geneva: International Organization for
Standardization; 2003.
TB_OB_GutsENG_H4IAU03.qxd:TT_OB_GutsENG.qxd 10/13/10 12:33 PM Page 39
To Next Page
Loading...
