Do the New FDA Guidance Documents Help Improving Performance of Blood Glucose Monitoring Systems Compared With ISO 15197?

J Diabetes Sci Technol. 2017 Nov;11(6):1240-1246. doi: 10.1177/1932296817713220. Epub 2017 Jun 6.


Recently, the Food and Drug Administration (FDA) published guidance documents for point-of-care testing (POCT) and over-the-counter (OTC) blood glucose monitoring systems (BGMS). These are expected to improve weaknesses of the already established ISO 15197:2013 standard accuracy evaluation for OTC BGMS; however, the proposed criteria and procedures rather raise new questions. As an example, the OTC guidance stipulates tighter accuracy criteria in the low glycemic range than the POCT guidance for no obvious reason. Furthermore, a clear definition of requirements for the reference method is missing under consideration of the strict accuracy criteria. External surveillance of BGMS after introduction to the market is an issue that is addressed neither in the FDA documents, nor in ISO 15197, but in the Clinical and Laboratory Standards Institute (CLSI) guideline POCT12-A3.

Keywords: CLSI guideline; FDA guidance; ISO 15197; POCT; SMBG; blood glucose monitoring system.

Publication types

  • Comparative Study

MeSH terms

  • Biomarkers / blood
  • Blood Glucose / metabolism*
  • Blood Glucose Self-Monitoring / instrumentation*
  • Blood Glucose Self-Monitoring / standards
  • Device Approval* / standards
  • Documentation* / standards
  • Humans
  • Monitoring, Ambulatory / instrumentation*
  • Monitoring, Ambulatory / standards
  • Practice Guidelines as Topic
  • Predictive Value of Tests
  • Reproducibility of Results
  • Time Factors
  • United States
  • United States Food and Drug Administration* / standards


  • Biomarkers
  • Blood Glucose