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Final FDA Guidance Clarifies Distinction Between Medical Device Recalls and Enhancements

20 October 2014

Medical Device Alert

On 15 October 2014, the Food and Drug Administration issued its final guidance clarifying the difference between medical device recalls and device enhancements. This document replaces the draft guidance issued by the agency in February 2013.

Read More: Final FDA Guidance Clarifies Distinction Between Medical Device Recalls and Enhancements

The team

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