FDA takes steps to advance the safety and accuracy of blood glucose monitors

FDA on Thursday issued two revised draft guidances regarding blood glucose monitors used in health care and home settings: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use and Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.

FDA on Thursday issued two revised draft guidances regarding blood glucose monitors used in health care and home settings: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use and Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. These new draft guidances, when finalized, will update two final guidances issued in 2016. The changes are based on additional feedback from stakeholders requesting more clarification on design considerations and recommended standards. The action is part of the agency's efforts to improve the development of new blood glucose meters based on feedback from both patients and health care providers, especially on the usability of glucose monitors. The two draft guidances provide recommendations to industry about the types of information to be included in their premarket submissions for these devices. FDA is seeking comments on the revised draft guidances. These revisions do not change the recommended studies, the performance goals, or the pathway to obtaining Clinical Laboratory Improvement Amendments waiver for these devices.