Proposed new guidance is out today from FDA on blood glucose meter systems (BGMS). There are two documents. One for patent users and one for use in clinical settings such as hospitals. I am still reading them but I thought other may wish to do so too..
MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/UCM380327. pdf
Starting at line 420, page 11,
... you should demonstrate that 95% of all SMBG results in this study are within +/- 15% of the reference measurement across the entire claimed measuring range of the device ...
There are actually two pieces of proposed guidance, over the counter (linked above) and point of care. The later is at:
MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/UCM380325. pdf
That document for BGMS use by HCPs in clinical stetting states (starting at line 277, p9):
Although many manufacturers design their BGMS validation studies based on the International Standards Organizations document 15197, FDA believes that the criteria set forth in the ISO 15197 standard do not adequately protect patients using BGMS devices in professional settings, and does not recommend using these criteria for BGMS devices.