Why the New FDA Glucose Meter POCT Guidance Is Disappointing
Author:
Affiliation:
1. Krouwer Consulting, Sherborn, MA, USA
Publisher
SAGE Publications
Subject
Biomedical Engineering,Bioengineering,Endocrinology, Diabetes and Metabolism,Internal Medicine
Link
http://journals.sagepub.com/doi/pdf/10.1177/1932296816682763
Reference4 articles.
1. Wrong Thinking about Glucose Standards
2. A Review of Standards and Statistics Used to Describe Blood Glucose Monitor Performance
3. Why specifications for allowable glucose meter errors should include 100% of the data
4. The New Glucose Standard POCT12-A3 Misses the Mark
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2. Evaluation of Precision and Bias Specifications Required to Achieve the 2018 FDA Guidance Criteria for Glucose Meter Performance Using Simulation Models;Journal of Diabetes Science and Technology;2019-11-21
3. Accuracy of Using a Point-of-Care Glucometer for Cerebrospinal Fluid Glucose Screening in Resource-Limited Countries;Hospital Pediatrics;2019-09-01
4. Postmarket Surveillance of Blood Glucose Monitor Systems Is Needed for Safety of Subjects and Accurate Determination of Effectiveness in Clinical Trials of Diabetes Drugs and Devices;Journal of Diabetes Science and Technology;2019-04-11
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