American Association for Clinical Chemistry
Better health through laboratory medicine

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Concerned that many labs may not be following established protocols for using RUO/IUO products, the FDA recently released a final guidance that spells out the responsibilities of manufacturers that distribute IVD products labeled for research use and investigational use. Although the guidance is directed towards manufacturers, clinical labs are concerned that: manufacturers may stop selling RUO/IUO reagents; that restricted access to RUO/IUO reagents may stymie the development of new, innovative tests; and that manufacturers may limit sales of RUO/IUO instruments, such as tandem mass spectrometers, out of concern that they will be used to generate clinical diagnostic results. Join us for this 60-minute webinar and learn which concerns are valid, which are unwarranted, and what you would need to do to be in compliance.