Office of Device Evaluation releases annual performance report

The FDA department charged with evaluating medical devices issued its annual performance review for 2009, showing a slight uptick in overall submissions. The Office of Device Evaluation's report reveals that total submissions increased 0.6 percent from 2008 to 2009. There was a sharp drop in PMA applications and a 7 percent increase in 510(k) submissions, from 3,363 in 2008 to 3,597 in 2009. Report | Article