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Abstract Details
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Activity Number:
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325
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304735 |
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Title:
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Quality Statistical Review Checklist of Investigational Device Exemption (IDE) Submissions for Diagnostic Medical Devices
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Author(s):
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R. Lakshmi Vishnuvajjala*+
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Companies:
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FDA/CDRH
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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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IDE ;
Diagnostic ;
Device ;
CDRH
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Abstract:
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This paper discussions the checklist used for internal quality review procedures for the statistical review of diagnostic Investigational Device Exemption (IDE) submissions to the FDA's Center for Devices and Radiological health. It steps through the key elements a statistical reviewer would evaluate while reviewing the submission.
An IDE for a diagnostic device should include several necessary elements in order for FDA to determine if it meets the threshold in protecting intended patients and having a well planned trial. Some of the required elements include a clear description of the target condition, intended subjects as well as intended users of the device. For example, some devices can only be used by healthcare professionals or lab technicians, and others can be used by lay users and caregivers. It should also include a clear description of the study, the statistical plan and sam
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Authors who are presenting talks have a * after their name.
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