FDA Issues Recommendations for Industry to Improve Blood Glucose Monitoring Test Systems

October, 2016

October 11, 2016. The US Food and Drug Administration has released a final guidance document: “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use” (ie, home use). Its purpose is to improve new blood glucose meters by providing manufacturers with recommendations regarding the types of studies and information to include in premarket 510(k) submissions for these devices. A second guidance document, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/... blood glucose monitoring for hospital use, focused on point-of-care blood glucose monitoring for hospital use, is also now available. Click here for full article