Our Webinar held on

Thursday, August 11, 2011


Click one of the links below...


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:

  • Understand what information FDA evaluates to grant marketing clearance for POC glucose meters

  • Learn what the performance criteria is that POC glucose meters must meet

  • 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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