FDA Posts Shorter 510(k) and PMA Approval Times

December 6, 2012

The FDA released the “Results of CDRH’s Plan of Action for Premarket Review of Devices,” which announced that the FDA review times under the 510(k) process have improved. The Plan of Action was designed to increase the predictability, consistency, transparency, efficiency and timeliness of device premarket reviews. Positive results from implementing the Plan of Action include:

  • A decrease in the average time it takes to clear a 510(k) began in 2011, for the first time since 2005;
  • An almost two-thirds drop in the backlog of 510(k)s pending for more than 90 FDA-days;
  • An approximately one-third decrease in the average time it takes to reach a decision on a PMA; and
  • An increase in the percentage of submitted 510(k)s cleared and PMAs approved without lowering the bar for clearance or approval, which indicates improvement in the quality of applications and the consistency of review standards.

The Plan of Action hopes to create greater efficiency and predictability that will facilitate innovation, especially for small and start-up companies that need venture capital to fund their development of new technologies. In addition to the Plan of Action, the FDA has instituted several other programs to support device innovation. The programs include:

  • Intense early collaboration between the FDA and device innovators;
  • An entrepreneurs-in-residence program;
  • Creating incentives for device developers to conduct their clinical studies first in the United States; and
  • Improving collaboration with CMS with the goal of reducing the time between approval and reimbursement of innovative devices.

If you have any questions about the 510(k) or PMA processes, please contact one of the authors.