APR 07, 2016 07:30 AM PDT

Evidence Required by FDA for Establishing Clinical Validity

  • Director, Office of In Vitro Diagnostics, CDRH
      Alberto Gutierrez is the director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the Food and Drug Administration. Gutierrez has had a longstanding career with the FDA, joining in 1992 as a reviewer in the FDA's Center for Biologics Evaluation and Research working on vaccine adjuvants and method development for determination of the purity and structure of vaccine components. In 2000, he joined the FDA Center for Devices and Radiological Health as a scientific reviewer, becoming a team leader for Toxicology in 2003, director of the Division of Chemistry and Toxicology Devices in 2005, deputy director of the Office of In Vitro Diagnostic Device Evaluation and Safety in 2007, and office director in 2009. He holds a bachelor's degree from Haverford College and master and doctorate degrees in chemistry from Princeton University.


    In this webinar the speaker discusses the approach taken by the Food and Drug administration in their pre-market review of in vitro diagnostic tests.  The legal bar passed by congress in the medical device amendment to the Federal Food and Cosmetic Act defined that the Agency needs to ascertain that there is a reasonable assurance that the device is safe and effective.  The talk explores how the FDA interprets that with respect to the analytical and clinical validity of a test and what that means in practical terms as the Agency weighs the risks and benefits of the device to make its determinations.  Two examples are put forth to show the difference between the review of a moderate risk device for which the clinical validity has been well established, and a new type of device that needs to demonstrate clinical validity.

    Learning Objectives:

    1.  To understand how the FDA evaluates in vitro diagnostic tests.
    2.  To learn the relationship between the safety and effectiveness of an in vitro diagnostic test and the test clinical validity.

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