FDA Finalizes Two Guidance Documents on Blood Glucose Monitoring Systems
The Food and Drug Administration (FDA) on Friday finalized two guidance documents related to blood glucose monitoring systems (BGMSs), offering new recommendations on the different types of information in 510(k)s for BGMSs used by health professionals versus SMBGs intended for home use by lay users.
FDA says the guidance was necessary as it has become increasingly clear that these different use settings have distinct intended use populations with unique characteristics that can impact device design specifications, and that manufacturers should take these unique characteristics into account when designing their devices.
The guidance comes as the Centers for Medicare and Medicaid Services and Centers for Disease Control and Prevention revealed concerns related to the possibility that blood glucose meters can transmit bloodborne pathogens if these devices are contaminated with blood specimens and shared between users without effective cleaning, disinfecting and appropriate infection control measures.
Both guidance documents, "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use" and "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use," describe studies and criteria that FDA recommends could be used when submitting premarket notifications (510(k)s) for both types of systems. FDA intends for the documents to serve as guides for manufacturers in conducting appropriate performance studies and preparing 510(k)s for these device types.