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Https://www.cola.org /insights-newsletter S/2015/Nov/insights. Pdf.pdf

insights.pdf
Preview of https://www.cola.org /insights-newsletter s/2015/Nov/insights. pdf
🔗 Source: cola.org
📊 Size: 822 KB
📄 Pages: 12 pages
⬇️ Downloads: 46

Summary

Laboratory Developed Tests (LDTs) are facing increased federal oversight due to their growing role in personalized medicine and high-complexity procedures. The FDA is re-assessing its policy of "enforcement discretion" for LDTs, which are developed and used by clinical laboratories without FDA approval. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulate LDTs, focusing on accuracy and reliability, but there is concern that this may not be enough to ensure the quality of these tests. Meanwhile, a new rule promotes burden reduction for Proficiency Testing (PT), with a three-tiered system of penalties for labs that break the rules.

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Description

Laboratory Developed Tests (LDTs) are facing increased federal oversight due to their growing role in personalized medicine and high-complexity procedures.

Technical Information

  • File Format: PDF
  • File Size: 822 KB
  • Pages: 12
  • Language: EN
  • Total Downloads: 46
  • Last Updated: 1 month ago

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