Neurology

FDA-approved neurologic devices for use in children reviewed

Published in Medical Letter on the CDC and FDA, December 26th, 2004

Researchers review FDA-approved neurologic devices intended for use in infants, children, and adolescents in a recent issue of the journal Neurology.

According to a study from the United States, "The U.S. Food and Drug Administration (FDA) has approved several applications for the marketing of neurologic devices. Nineteen high-risk Class III medical devices were approved for the central and peripheral nervous system for marketing between 1994 and 2003, and almost half (n=8) include indications for use in children as well as adults."

"On July 24, 2003, the FDA Center for Devices and Radiologic Health released for public comment a draft guidance...

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Source: Medical Letter on the CDC and FDA (2004-12-26)

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