| The food and drug administration is now preparing to establish tighter performance requirements for blood glucose monitors. | |
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MedLine Citation:
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PMID: 20513313 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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On March 16 and 17, 2010, the Food and Drug Administration (FDA) presented a public meeting about blood glucose monitoring at the Gaithersberg Hilton Hotel. The meeting was intended to present expert opinions and solicit input from the public about whether to develop new regulatory policies for blood glucose monitors. The meeting was divided into three sections: (1) Clinical Accuracy Requirements for Blood Glucose Monitors, (2) Interferences and Limitations of Blood Glucose Monitors, and (3) Tight Glycemic Control. Many officials from the Center for Devices and Radiologic Health and the Office of In Vitro Diagnostic Devices, which are the parts of FDA that regulate approval of blood glucose monitors, either spoke on the agenda or attended in the audience. Approximately 300 people attended; they were mostly clinicians (such as adult endocrinologists, pediatric endocrinologists, internists, clinical chemists, intensivists, surgeons, nurses, and diabetes educators) or industry officials from companies involved in glucose monitoring, pharmaceutical products, data analysis, or regulatory consulting. |
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Authors:
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David C Klonoff |
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Publication Detail:
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Type: Congresses Date: 2010-05-01 |
Journal Detail:
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Title: Journal of diabetes science and technology Volume: 4 ISSN: 1932-2968 ISO Abbreviation: J Diabetes Sci Technol Publication Date: 2010 May |
Date Detail:
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Created Date: 2010-06-01 Completed Date: 2010-11-16 Revised Date: 2011-07-28 |
Medline Journal Info:
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Nlm Unique ID: 101306166 Medline TA: J Diabetes Sci Technol Country: United States |
Other Details:
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Languages: eng Pagination: 499-504 Citation Subset: IM |
Copyright Information:
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(c) 2010 Diabetes Technology Society. |
Affiliation:
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Mills-Peninsula Health Services, San Mateo, California 94401, USA. dklonoff@yahoo.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Blood Glucose
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analysis* Hematologic Tests / instrumentation*, standards* Humans United States United States Food and Drug Administration / standards* |
| Chemical | |
Reg. No./Substance:
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0/Blood Glucose |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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