November 2012 

Read the Report: Printable PDF (1.86 MB)

In January 2011, the FDA announced a Plan of Action to modernize and improve the FDA’s premarket review of medical devices. In the two years since FDA began implementing the plan, the speed and predictability of device review have improved for the first time in almost a decade, including significant reductions in the time it takes FDA to review applications and the size of application backlogs.

• The average time it takes to clear a 510(k) began declining in 2011, for the first time since 2005;
• The backlog of 510(k)s pending for more than 90 FDA-days, which increased steadily since 2005, dropped by almost two-thirds, from its high in 2010;
• The average time it takes to reach a decision on a PMA has been reduced by about one-third since 2010; and
• Without lowering the bar for clearance or approval, the percentage of submitted 510(k)s that are cleared and PMAs that are approved has increased since 2010, indicating improvements in the quality of applications and the consistency of review standards.