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Posted On: 11/30/2018 1:24:08 PM
Post# of 11802
FDA issues 2 revised draft guidances for blood glucose meters
https://www.healio.com/endocrinology/diabetes...ose-meters
https://www.fda.gov/downloads/MedicalDevices/...626742.pdf
It seems for the time being there are no changes in accuracy Standards. GenPrecis like Mr. Berman described in the interview will be way ahead and set a new standard.
https://www.healio.com/endocrinology/diabetes...ose-meters
Quote:
Your studies should demonstrate that your SMBG is 462 sufficient for this purpose by showing that 95% of all SMBG results in this study are within 463 +/- 15% of the comparator results across the entire claimed measuring range of the device 464 and that 99% of all SMBG results are within +/- 20% of the comparator results across the 465 entire claimed measuring range of the device
https://www.fda.gov/downloads/MedicalDevices/...626742.pdf
It seems for the time being there are no changes in accuracy Standards. GenPrecis like Mr. Berman described in the interview will be way ahead and set a new standard.
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