JSM 2005 - Toronto

Abstract #304175

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 408
Type: Luncheons
Date/Time: Wednesday, August 10, 2005 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304175
Title: Diagnostic Medical Devices
Author(s): Lakshmi Vishnuvajjala*+
Companies: U.S. Food and Drug Administration
Address: 1350 Piccard Drive HFZ 542, Rockville, MD, 20850, United States
Keywords: Diagnostic ; Medical Device ; In Vitro
Abstract:

Statistical methods for diagnostic devices are quite different from those for therapeutic devices and drugs. In particular, for in vitro diagnostic devices---which form a majority of devices regulated by the Center for Devices and Radiological Health at FDA---an Investigational Device Exemption (IDE) is usually not required as there is usually no risk to the patient. This makes communication between industry and FDA important to ensure proper study design and statistical methodology are followed. here are other devices that are not in vitro diagnostics, including devices using autofluorescence to diagnose conditions ranging from Strep to cancer. These devices often require an IDE, but when the patient is his/her own control, randomization is not always feasible.

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Revised March 2005