As the vast majority of moderate risk medical devices are cleared for marketing through the 510(k) process, these changes can have a substantial impact on the way industry does business. This presentation will discuss the background behind FDA’s decision to modify the 510(k) process, outline the progress it has made in 2011and 2012 to implement these changes, and take a look at what changes are yet to come in 2012 and beyond.
Added by Jay Sylvester on June 21, 2012