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CLIA Waiver Study Guidelines Simplified By US FDA In Latest Revisions

Executive Summary

FDA took the unusual step of issuing a second round of draft guidance documents in its effort to refine requirements for diagnostics companies seeking a CLIA waiver to allow point-of-care use of a test. The revised drafts are simplified compared to November 2017 versions, and they appear to line up more closely with industry arguments about what is needed to demonstrate "accuracy" in this context.

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FDA Finalizes CLIA Waiver Guidance Docs

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US FDA Emphasizes Computer Modeling, Existing Data For Least-Burdensome Device Submissions

FDA explains what qualifies as “the minimum information necessary,” including existing data, peer-reviewed data, and validated computer modeling, for new device and diagnostic applications, in a final “least burdensome” guidance released Feb. 4.

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Accuracy "is a widely used and generally understood term in clinical laboratory sciences," according to US FDA, but industry groups say the agency continues to misunderstand Congress' use of the word when it comes to CLIA waivers for point-of-care tests, including in a draft guidance document issued by the agency in recent days. FDA is also touting a new, more efficient approach to dual 510(k)-CLIA waiver submissions. 

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