title: Why the New FDA Glucose Meter POCT Guidance Is Disappointing.
authors.affiliation: 1 Krouwer Consulting, Sherborn, MA, USA.
authors.forename: Jan S
authors.initials: JS
authors.lastname: Krouwer
mesh_terms: D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000592:standards*; D018795:Device Approval / Q000592:standards*; D004867:Equipment Design; D006801:Humans; D061214:Patient Safety; D019095:Point-of-Care Systems / Q000592:standards*; D000067716:Point-of-Care Testing / Q000592:standards*; D017410:Practice Guidelines as Topic / Q000592:standards*; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
chemical_list: D015415:Biomarkers; D001786:Blood Glucose
keywords: glucose meter; performance standard