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FDA Director to Address the Final Guidance on Research and Investigational Use Only Devices

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SOURCE AACC

MEDIA ADVISORY

WASHINGTON, Feb. 25, 2014 /PRNewswire-USNewswire/ -- On February 26, AACC will host a webinar with Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health at FDA to discuss FDA's guidance on in vitro diagnostic products labeled for research use only (RUO) or investigational use only (IUO).

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WHO: Dr. Gutierrez has been director of FDA's Office of In Vitro Diagnostics since 2009, and is a leading expert on regulating and ensuring the safety of medical tests.

WHEN: Wednesday, February 26
2–3 p.m.

WHERE: A Q&A With the FDA on the RUO/IUO Final Guidance

WHY: Labs are concerned about the impact that the guidance (Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff) will have on them.

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.

About AACC
Dedicated to achieving better health through laboratory medicine, the American Association for Clinical Chemistry (AACC) brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.

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