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News & Perspective

January 27, 2015

Medical Device Recalls Up 97 Percent Over Last Decade, Hospitals Struggle to Keep Up

In an executive summary of its Medical Device Recall Report, the FDA revealed that the annual number of recalls increased by a staggering 97 percent from 2003 to 2012. Over the past decade, the complexity of medical device recalls increased...

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December 16, 2014

FDA Guidance Document Clarifies When Product Changes Establish Need for Recall

The FDA has instituted a final guidance document in order for companies to clearly distinguish a recall from a market withdrawal. Part of the draft version of the new guidance called for reporting of any enhancement of a product, a...

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