An overview of human factors engineering at CDRH in the safety and effectiveness of blood glucose meters.
Kaye
Ronald D
RD
The Office of Health and Industry Programs, Division of Device User Programs and Systems Analysis, Center for Devices and Radiological Health/FDA, 1350 Pickard Drive, HFZ-230, Rockville, MD 20850, USA. rdk@cdrh.fda.gov
Chenault
V Michelle
VM
D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000592:standards*; D003920:Diabetes Mellitus / Q000097:blood; D006801:Humans; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
D001786:Blood Glucose