FDA issued a draft guidance for prescription POC (Point-of-care) entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” This draft guidance document provides recommendations to industry about the types of information to include in their premarket submissions for blood glucose monitoring systems used for diabetes management in the health care prescription POC settings. This guidance identifies software information to submit including displays and user messages, user prompts and response time requirements, and error messages. A footnote indicates units that should be displayed. Appendix I indicates errors to consider including for software such as reporting of unrecognized signal errors.
See this draft guidance at: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.
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