FDA warning letters over medical devices 2009-2017

Number of warning letters the FDA sent concerning medical devices from 2009 to 2017*

by Matej Mikulic, last edited Oct 30, 2018
FDA warning letters over medical devices 2009-2017 This statistic shows the number of warning letters the Food and Drug Administration (FDA) sent concerning medical devices for fiscal years 2009 to 2017. In 2015, the FDA sent 168 warning letters to the appropriate responsible individual, manufacturer or facility informing them that their medical device was in violation of laws that the FDA enforces.
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Number of warning letters the FDA sent concerning medical devices from 2009 to 2017*

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