FDA Finalizes Two Guidance Documents on Blood Glucose Monitoring Systems

Friday, October 7, 2016

Source: RAPS

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. 

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