JSM Preliminary Online Program
This is the preliminary program for the 2009 Joint Statistical Meetings in Washington, DC.

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Activity Number: 175
Type: Roundtables
Date/Time: Monday, August 3, 2009 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304102
Title: Design and Analysis Issues for FDA Medical Device Submissions
Author(s): Gary Kamer*+
Companies: FDA
Address: , , ,
Keywords: regulatory/public health ; pivotal clinical studies ; common use
Abstract:

As a government regulatory/public health agency, FDAs Center for Devices and Radiological Health may make use of data from bench, animal, feasibility and pivotal clinical studies that may differ somewhat in design and/or analysis from studies of treatments, drugs or devices which are already in common use. Hopefully, the discussion will be general enough to examine this difference, yet specific enough to look at individual design and analysis methods, perhaps comparing them to alternatives.

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