FDA Issues Guidance on Blood-Glucose Monitoring Systems
October 5, 2020
The FDA has issued two final guidances on blood glucose monitoring systems, noting that both the point-of-care and over-the counter versions of the devices require 510(k) marketing clearance.
Blood-glucose meters in healthcare settings will probably be used with multiple patients, so devicemakers should take into account device design to limit blood-borne infections, the agency said.
The guidance calls for studies on participants in various states of health to assess the performance of devices intended to be used in diverse healthcare settings.