The American Association for Clinical Chemistry (AACC) and the American Society for Clinical Laboratory Science (ASCLS) will host a Webinar titled, A Q&A with the FDA on the RUO/IUO Draft Guidance. The Webinar will be held on October 5 at 2 pm Eastern and will last 90 minutes.

As technology evolves, clinical laboratories are increasingly using RUO/IUO (Research Use Only/Investigational Use Only) products to conduct laboratory tests. The Food & Drug Administration (FDA), responsible for oversight of the sale and use of associated reagents and instruments, is concerned that many laboratories are not following protocols for their use. To address this, the FDA recently released a draft guidance spelling out the responsibilities of manufacturers that distribute IVD products labeled for research or investigational use. The guidance states that manufacturers should not sell such products to a clinical laboratory if they know or “have reason to know" that they are being used for clinical diagnostic purposes. Although directed at manufacturers, the policy proposals may have implications for the clinical laboratory.

The expert for the Webinar is Alberto Gutierrez, PhD, director of the office of in vitro diagnostic device evaluation and safety (OIVD), FDA, Silver Spring, Md. He will answer questions from Patricia M. Jones, PhD, DABCC, FACB, and Jason Parks, MD, both from Children’s Medical Center, Dallas, Tex, as well as those registered for the event. The Webinar will be moderated by Robert Murray, JD, PhD, from Midwest Diagnostic Pathology, Chicago.

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Source: AACC