FDA warning letters over medical devices 2009-2015

Number of warning letters the FDA sent concerning medical devices from 2009 to 2015

The data displays the number of warning letters the Food and Drug Administration (FDA) sent concerning medical devices for fiscal years 2009 to 2015. 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.

2009 136
2010 204
2011 175
2012 210
2013 217
2014 114
2015 168