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The Meaning Of 'Accurate': Debate Continues With Latest CLIA Waiver Guidances

Executive Summary

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to misunderstand Congress' use of the word when it comes to CLIA waivers for point-of-care tests, including in a draft guidance document issued by the agency in recent days.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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FDA took the unusual step of issuing a second round of draft guidance documents in its effort to refine requirements for diagnostics companies seeking a CLIA waiver to allow point-of-care use of a test.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.

Dx Departure: US FDA's Diagnostics Chief Gutierrez Steps Down

Alberto Gutierrez left FDA and government this week in a planned retirement. He was director of the office that oversees pre- and post-market programs for in vitro diagnostics and radiology devices, an office where several holes already exist in top management slots.

21st Century Cures: Device Provisions

Dozens of reforms impacting the medtech sector were signed into law Dec. 13 as part of the 21st Century Cures Act. Here's a breakdown of the provisions most important to device- and diagnostic-makers.

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