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Abstract Details
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Activity Number:
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648
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 2, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305608 |
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Title:
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Some Issues in Method Comparison Studies for Diagnostic Medical Devices
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Author(s):
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Shanti Gomatam*+
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Companies:
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FDA
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Address:
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10903 New Hampshire Avenue, Silver Spring, MD, 20993-0002, United States
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Keywords:
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Agreement
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Abstract:
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Submissions for the clearance of diagnostic medical devices that make quantitative measurements often involve comparison of the test device's performance to that of a clinical reference standard or a marketed device. How should one approach such a comparison and what are appropriate supporting analyses? We will discuss various potential approaches with regards to their appropriateness, advantages and drawbacks.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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