FDA Watch: Mass Spectrometry Test Receives First Moderate Complexity Designation
Roche’s vitamin D assay includes internal quality controls that allowed it to obtain the CLIA designation
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CMS Clarifies CLIA Personnel Requirements in Rare Memo
Clinical labs gain flexibility in meeting regulatory standards while potentially reducing their costs
Could Labs Adopt a CLIA Framework for Regulating Clinical AI?
Learn how CLIA could be used as a blueprint to regulate emerging technologies in an effective and dynamic way
After Nearly 3 Decades, CMS Proposes Updates to Proficiency Testing Rules
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Brief Your CEO: After 36 Years, CLIA Comes Under CMS Review
From - G2 Compliance Advisor
Even as your lab makes the transition to the new, supposedly market-based PAMA Medicare Part B fee schedule for tests, big changes may be in store for another rock of…
CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency
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Theranos Faces New Challenges and Increasing Federal Scrutiny
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CMS Issues Deficiency Letter to Theranos
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FDA’s 2016 Guidance Plans Include LDTs and Other Diagnostics Topics
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FDA and CMS Address LDT Regulation Before Energy and Commerce Committee
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AMP Offers Proposal for Regulation of Laboratory Developed Tests
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Outcome of LDT Regulation Controversy Defies Forecasting
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