glucose Archives

Dec

FDA Draft Guidance Prescription POC

December 11, 2018Brian PateNews

FDA issued a draft guidance for prescription POC (Point-of-care) entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” This draft guidance document provides recommendations to industry about the types of information to include in their premarket submissions for blood glucose monitoring systems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...

Dec

FDA Draft Self-Monitoring OTC Glucose Test Systems

December 11, 2018Alan KusinitzNews

FDA issued a draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use“‘. This draft guidance document provides recommendations to industry about the studies and criteria to include in their premarket submissions for self-monitoring blood glucose test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)...

FDA Draft Guidance Prescription POC

FDA Draft Self-Monitoring OTC Glucose Test Systems

SoftwareCPR Training Courses

Corporate Office

Tag

FDA Draft Guidance Prescription POC

FDA Draft Self-Monitoring OTC Glucose Test Systems

SoftwareCPR Training Courses

Corporate Office