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The FDA released two draft guidances that establish a line between over-the-counter and point-of-care blood glucose monitors.
In the past, the agency didn't distinguish between consumer and professional uses of blood glucose monitors, but now they want to make the distinction since there are differences in the way professionals and consumers handle them.
Consumer-facing devices may need to be more robust and reliable, according to the guidance, since these are likely to face more varied storage and handling conditions, while medical professionals "are generally more proficient at performing testing and at running appropriate controls."
Both documents discuss study requirements and data analysis, with a major difference being that professional devices must be evaluated in the neonatal population.
will have to be made for single-patient use to prevent the risk of transmitting bloodborne pathogens like viral hepatitis, and they'll have to be easy to clean and disinfect.
The same stringent disinfectant regimens will be required of , with a focus on infection control to prevent hospital-borne infections.
These professional devices may be held to more rigorous standards given that the stakes are higher, as patients in these settings "are fundamentally different than lay users." They may be acutely ill and medically fragile, so errors can lead to delays in insulin dosing that may lead to more episodes of hypoglycemia and conditions with unfavorable outcomes.
Both documents are up for a 90-day comment period.