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U.S. Department of Health and Human Services

Medical Devices

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Revelations in In Vitro Diagnostic (IVD) Device Labeling - Proactive Prevention of Adverse Events by Informed Decision Making

Source: Medical Product Safety Network (MedSun) Newletter #35, April 2009.

Picture this: a representative from a large, reputable company has just finished training your staff in the use of their best-selling IVD device. Each technician has passed their proficiency test and has been cleared by the company to run the assay. The instrument has been installed and calibrated and all validation runs are complete. You are ready to go, right? Wait! Don’t forget to carefully read the package insert. In this MedSun article, FDA’s Office of In Vitro Diagnostics provides tips to help you ensure that any new IVD device will not be misused in your laboratory.