The United States Food and Drug Administration released a report on the success of its “Plan of Action” for streamlining premarket approval of medical devices. The 36-point plan is designed to lower the application backlog and reduce device review times. According to the FDA, the regulatory agency’s earlier approval process had several significant weaknesses.

The FDA report detailed that the agency “successfully increased the predictivity, consistency, transparency, efficiency and timeliness of premarket review.” The new plan is the result of a concentrated two-year effort that included a drive to improve agency resource management and remove unneeded regulatory requirements. In addition, the agency brought in consultants from outside the FDA to help improve internal review processes.

The agency’s Plan of Action was first launched at the beginning of last year. However, some of the plan’s initiatives were undertaken in 2010. At this time, medtech review trends at the FDA were at their worst levels.

According to a report by the agency, the previous decade had been met a variety of unsolved challenges. For example, the average length of review could stretch on for months. In addition, the number of backlogged applications had increased significantly.

PMA review times at the agency have dropped by one third since 2010. In addition, the backlog of 510(k)s that are pending for over 90 days has dropped by almost two thirds from the highest level in 2010.

References

www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM329702.pdf