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Expert Analysis

Recall Or Enhancement? Read These Medical Device Rules

Law360, New York (October 31, 2014, 10:43 AM EDT) -- On Oct. 15, 2014, the U.S. Food and Drug Administration's Center for Devices and Radiological Health issued a final guidance document, Distinguishing Medical Device Recalls from Medical Device Enhancements.[1] The guidance follows and revises a draft guidance document, Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements, issued on Feb. 22, 2013.[2]...

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