Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use | FDA

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use | FDA

FDA Issues Final Guidances on Blood Glucose Monitoring Test Systems

Today, the U.S. Food and Drug Administration (FDA) issued two updated final guidances intended to improve the accuracy, reliability, and safe use of blood glucose monitoring test systems:  

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use

This guidance provides recommendations to industry about the types of information to include in premarket submissions for blood glucose monitoring systems used for diabetes management in the health care setting.

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use

This guidance provides recommendations to industry about the studies and information to include in premarket submissions for self-monitoring blood glucose test systems used for diabetes management in the home setting.

These guidances replace the versions issued in October 2016 and the drafts from November 2018.

Questions?

If you have any questions about these guidances, contact the Division of Industry and Consumer Education (DICE).