Medical Devices

FDA regulation of in vitro diagnostic devices reviewed

Published in Medical Letter on the CDC and FDA, May 22nd, 2005

Researchers describe the U.S. Food and Drug Administration (FDA) regulation of in vitro diagnostic devices in a recent issue of the Journal of Molecular Diagnostics.

According to a study from the United States, "The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to most clinical laboratory scientists. In this article we briefly describe the criteria that are used to classify and review in vitro diagnostic devices. We discuss the similarities and differences between devices that are not subject to premarket review, and those that are required to undergo either a...

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Source: Medical Letter on the CDC and FDA (2005-05-22)

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