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Public Will Have Access To "Real-Time" Recall Data

This article was originally published in The Silver Sheet

Executive Summary

MEDICAL DEVICE RECALLS REACH A NEW HIGH IN 2002 at 585, a 10% rise over the previous benchmark set in 2001. Nearly 75% of 2002 recall actions placed in Class II. The upward trend in recalls comes as FDA prepares to launch a new, Internet-based recall system. With the "Recall Enterprise System," the agency aims to provide "real-time" information via the web on corrections and removals actions. The new system is expected to challenge the ability of both manufacturers and FDA to efficiently evaluate and process recall data. [A tabulation of device recalls from 2002 is included]
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