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What the FDA’s Proposed Rule to Regulate Lab-Developed Tests Means for Hospitals and Health Systems
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What the FDA’s Proposed Rule to Regulate Lab-Developed Tests Means for Hospitals and Health Systems
ARUP expert, Jonathan Genzen, MD, PhD, chief medical officer and senior director of governmental affairs, answers questions about a proposed FDA rule to regulate laboratory-developed tests (LDTs) as medical devices, which will potentially limit patient access to essential medical care. He’ll address patient safety, test availability, and the impact on innovation. ARUP’s compliance officer, Jonathan Carr, JD, moderates the Q&A session. ARUP’s public comment, the slide desk for this presentation, as well as articles and other industry resources are available at www.aruplab.com/fda-ldt
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