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.