FDA Falls Short On Medical Device Monitoring: Report

Law360, New York (November 5, 2010, 2:55 PM EDT) -- The U.S. Food and Drug Administration needs to improve its post-approval monitoring of medical devices in order to better protect the public, a recently released report claims.

Most medical devices currently available for sale are backed up by studies that are “underpowered” to pick up on rare but potentially fatal events, placing large numbers of patients at risk if such devices are widely used, according to the paper published Nov. 3 in the British Medical Journal.

The report, penned by journalist Jeanne Lenzer and Shannon Brownlee...
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