FDA guidance aims to clarify device enhancements, recalls

02/26/2013 | MassDevice.com (Boston)

Draft guidance released by the FDA aims to clarify scenarios where changes to medical device design warrant a recall and help medtech firms differentiate those cases from product enhancements that do not constitute a recall. The guidance also outlines the regulatory standards for reporting a recall or product enhancement.

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MassDevice.com (Boston)

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