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Activity Number:
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407
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 9, 2006 : 10:30 AM to 12:20 PM
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Sponsor:
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Section on Statistics in Epidemiology
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| Abstract - #306674 |
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Title:
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Statistical Issues in Diagnostic Devices Including ROC Methods
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Author(s):
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R. Lakshmi Vishnuvajjala*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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1350 Piccard Drive, Rockville, MD, 20850,
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Keywords:
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diagnostic devices ; PMA ; gold standard ; review checklist
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Abstract:
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The diagnostic devices branch in the Division of Biostatistics at CDRH developed a checklist of items to look for in diagnostic submission. We initially thought of it for pre-market applications, but found it to be useful for 510(k)s as well. Because the statistical methodology for diagnostic devices is not as developed as it is for therapeutic devices, we thought it useful for manufacturers also.
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