Industry Points Out Transparency Issues With FDA Device Plan

Law360, New York (September 10, 2012, 8:50 PM EDT) -- Industry representatives and physicians on Monday praised the U.S. Food and Drug Administration's proposal to increase its post-approval monitoring of medical devices, though they expressed concern about the level of transparency the initiative requires and the standards for deeming a device unsafe.

The FDA proposed changes to its current post-market surveillance system Thursday that are designed to allow it to track device safety issues in near real time. Under the current system, problems with devices are reported haphazardly and somewhat infrequently, and often do not include...
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