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Summary:
More than 250 people attended this presentation,
led by Patricia A. Bernhardt,
B.S., MT(ASCP) Office of In Vitro Diagnostic
Device Evaluation and Safety
Center for Devices and Radiologic Health. Patricia provided
an overview of how POC blood glucose meters are regulated by FDA
and how the performance is evaluated and characterized.
Objectives: After
viewing this webinar, attendees will:
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Understand what information FDA evaluates
to grant marketing clearance for POC glucose meters
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Learn what the performance criteria is that
POC glucose meters must meet
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Understand who the intended users of POC
glucose meters are, and why they are not intended to be used
by everyone
Vendor Sponsors: Alere; Eurotrol;
HemoCue; Medical Automation Systems
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