The FDA released a report today detailing its stats for pre-market approvals and 510(k) applications for 2015 and the 1st 3 months of 2016, hitting a high-water mark for its time-to-decision for PMAs.
The FDA reported a significant improvement in the average decision time for PMAs, which cover high-risk Class III devices, clocking in at an average of 209 days. That’s a 20% improvement from last year’s average of 262 days, and the lowest time to decision on record for the federal safety watchdog.
The FDA said its percentage of PMAs approved dipped to 91% in the 1st 3 months of 2016, a 7% fall from its record high 98% approval rate in 2015. The numbers are still 5% higher than they were in 2014 at 86%.
For simpler 510(k)s, the agency reported stable numbers in the 1st 3 months of 2016, at 85%. That’s the same as the FDA clocked in 2015 and only 1% higher than its rate of approval in 2014.
The average time to 510(k) decisions decreased 14%, falling from 127 days in 2014 to 109 days in 2015, the lowest time to decision the agency has seen since 2006.
