FDA: Avg time to decision for PMAs at record levels

The FDA released a report today detailing its stats for Premarket 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 209 days. That’s a 20% improvement from last year’s average of 262 days, and the lowest time to decision on record with the organization.

The agency 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 in 2015 and only 1% higher than its rate of approval in 2014.

The average amount of 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.

The post FDA: Avg time to decision for PMAs at record levels appeared first on MassDevice.

from MassDevice http://ift.tt/1R7Ektj