JSM Preliminary Online Program
This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

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Activity Number: 156
Type: Roundtables
Date/Time: Monday, July 30, 2007 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #308981
Title: Innovative Design and Analysis of FDA Medical Device Submissions
Author(s): Gary Kamer*+
Companies: Food and Drug Administration
Address: 1350 Piccard Drive, Rockville, MD, 20850,
Keywords: FDA ; submissions ; innovative ; methodologies ; frequentist
Abstract:

This discussion will emphasize the acceptability of recently developed statistical methodologies to establish the safety and effectiveness of new medical devices seeking to be marketed in the United States. It is anticipated that there will be a broad range of methodologies discussed, along with their strengths, weaknesses, and alternatives. Concentration will be on frequentist procedures, but Bayesian issues also may be addressed.

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Revised September, 2007