The American Association for Clinical Chemistry (AACC) is hosting a Webinar titled, “A Q&A with the FDA on the RUO/IUO Draft Guidance.” The Webinar will take place on Wednesday October 5.
As technology continues to evolve, clinical laboratories are increasingly using RUO/IUO products to conduct new and vital laboratory tests. The Food and Drug Administration is concerned that many laboratories are not following the protocol for using these products.
To address this issue, the FDA recently released a draft guidance that spells out the responsibilities of manufacturers that distribute IVD products labeled for research use and investigational use. The document states that manufacturers should not sell RUO/IUO products to clinical laboratories if they know or have "reason to know" the laboratory is using them for clinical diagnostic purposes. This policy proposal, although directed towards manufacturers, may have serious implications for clinical laboratories.
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