New Blood Glucose Meter Guidance Unveiled: A Discussion with the FDA

  • Duration: 61 Minutes

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This webcast originally aired as a live webinar sponsored by AACC on March 19, 2014. The FDA is in the process of establishing different submission requirements for blood glucose meters—one set of criteria for instruments used in professional settings, the other for home use meters. Although the intent is to improve patient care, these draft guidance documents, if implemented, could have far-reaching implications for device manufacturers and those who use the blood glucose monitors they produce. View this program and learn how blood glucose meters are currently regulated; understand the new professional use requirements; and listen to a rapid-fire question-and-answer session with real questions from laboratorians and device manufacturers.