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February 19, 2007

Device Recalls Reach New High In 2006 As FDA Works On Postmarket Issues

From the February 2007 issue of "The Silver Sheet"

Despite a 27 percent drop in class I device recalls in 2006, overall recalls logged by industry rose 5 percent to 616 – the highest number recorded since FDA issued its 1997 correction and removals regulation.

Tim Ulatowski, director of CDRH’s Office of Compliance, says there are various reasons why recalls increased, including an overly relaxed manufacturer stance toward supplier controls and outsourcing.

FDA also is concerned about companies mischaracterizing field actions “as maintenance or some other follow-up” rather than recalls, Ulatowski says.

Meanwhile, the agency plans to improve risk communications with a consumer Web site.

This article continues in the February 2007 issue of "The Silver Sheet"

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Also covered in this issue:

COMPLETE TABLE OF RECALLS FROM 2006 includes 19 Class I (3%), 482 Class II (78%) and 115 Class III (19%) medical device events.

WARNING LETTERS: Craftmatic Organization cited for QS and MDR regulation violations in relation to problems with its AC-powered adjustable beds; two clinical investigators violate IDE and human subject protection regulations.

IN BRIEF: Custom Ultrasonics is latest manufacturer to sign consent decree with FDA; President Bush’s proposed 2008 budget includes 5 percent increase for FDA device activities.

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