With technology evolving rapidly in today’s healthcare world, increasing numbers of clinical labs are using RUO/IUO products to conduct important medical tests. These products can have unproven performance characteristics. With its guidance on RUO/IUO, FDA seeks to protect patients from the negative health consequences that could arise if they are treated based on the results of such tests. While the guidance is directed toward manufacturers of RUO/IUO products who must ensure the labeling for their products is consistent with how they are supposed to be used, some think it may seriously impact the ability of clinical labs to serve patients. FDA understands that research and investigational use in vitro diagnostics need to be available for unique uses and claims this guidance will not disrupt the development of these products. However, many tests depend on instruments that are often labeled as RUO, and certain specialty tests for rare disorders would not be possible without RUO/IUO reagents. Furthermore, use of RUO/IUO products in the past has led to the development of cutting-edge diagnostic tests that have advanced patient care. During the AACC webinar, Dr. Gutierrez will discuss and answer questions about FDA’s guidance on in vitro diagnostic products labeled RUO/IUO.