Dec 11, 2012

The US Food and Drug Administration has published a new report showing small but consistent reductions in review times for 510(k) premarket notification as well as premarket approval (PMA) submissions for medical devices.

The regulator attributes these new timeframes to its 36-point Plan of Action begun in early 2011 to improve premarket review processes through increased transparency, predictability and efficiencies.

FDA 510(k) Improvements
According to FDA data, the average time to decision for 510(k) medical device applications declined from 147 days in 2010 to 143 days in 2011—perhaps suggesting a gradual reversal of the trend over the past five years of lengthening review times.

The report also shows increasing percentages of 510(k) submissions determined to be Substantially Equivalent (SE). So far in 2012, 80% of premarket notification applications received by the FDA have been granted SE status, up from 78% of applications in 2011 and 73% in 2010. SE determinations had declined steadily between 2004 and 2010, but now those percentages appear on the rebound.

Although still at a historic high, the percentage of 510(k) applications garnering Additional Information (AI) requests may also be leveling off: 74% of 510(k) submissions in 2012 have received AI requests, down from 75% of submissions in 2011 and 77% in 2010. (Only 36% of 510(k) submissions received AI requests in 2002.)

PMAs: Still Lengthy, but Less So
The FDA report also claims shorter timeframes for PMA approvals following implementation of its Action Plan for medical devices. The average review time for PMAs fell from 389 days in 2009 and 354 days in 2010 to 266 days last year.

The percentage of PMA medical device submissions assigned major deficiency letters during their first FDA review cycles, however, has risen from 70% in 2011 to 74% in 2012; both those figures are down from 86% in 2010. Furthermore (and more importantly), overall percentages of PMAs approved by the FDA have remained steady at 70% for both 2012 and 2011, up substantially from 59% in 2010.

Obviously the PMA process will remain the FDA’s most rigorous and time-consuming review method given the high-risk nature of the devices that fall under this category. But based on the numbers presented by the FDA’s report, PMA reviews for the time being appear less onerous than in previous years.


  • Stewart Eisenhart