FDA issued a draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use“‘. This draft guidance document provides recommendations to industry about the studies and criteria to include in their premarket submissions for self-monitoring blood glucose test systems used for diabetes management in the home setting. This guidance (similar to the Prescription POC 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.

You can find the draft guidance on the FDA website or view/download at this link:  2018-11-30-FDA Draft Self-Monitoring OTC Glucose Test Systems