JSM 2004 - Toronto

Abstract #301653

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Activity Number: 123
Type: Luncheons
Date/Time: Monday, August 9, 2004 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301653
Title: Diagnostic Devices - SOLD OUT
Author(s): Lakshmi Vishnuvajjala*+
Companies: U.S. Food and Drug Administration
Address: 1350 Piccard Dr., HFZ-542, Rockville, MD, 20850,
Keywords: diagnostic ; CDRH ; monitors ; test kits
Abstract:

Diagnostic devices comprise over a third of all device submissions to the center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). These include in vitro diagnostic tests like tests for cholesterol, PSA, hepatitis, and glucose and tests for genetic markers and cancer markers, and home test kits for various conditions. Also included are radiological devices like mammography and x-ray, and other diagnostics devices that use ultrasound and autofluorescence. There are diagnostic devices in every area from fetal monitors to cardiac monitors, and fluorescence to detect cervical cancers and throat infections. The methodologies are different from those used for therapeutic devices, and emerging technologies present particular challenges to this area of devices.

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Revised March 2004