FDA on Record Approval Pace in 2015

A new report from EP Vantage says that in the first half of 2015, the FDA has already approved 26 devices with either premarket approval (PMA) or a humanitarian device exemption (HDE). That’s more PMAs and HDEs for new devices than for all of 2009, 2010 or 2013, said the report.

At this rate, the agency is on target to approve more such devices than in any individual year in the past decade.

One Ortho Device Approved

We checked the FDA PMA record for orthopedic devices. Only one Original PMA has been granted so far this year. That was in May for Vertiflex Inc.’s Superion Inter Spinous Spacer. There have been 16 Supplemental Approvals granted for orthopedic devices for things such as post-approval studies, changes in vendors and updates in packaging or manufacturing processes. DePuy Synthes and Medtronic plc led the way in Supplemental Approvals with eight and five respectively.

According to EP Vantage, the average review for devices granted a PMA or HDE took 17.1 and 16.7 months, respectively.

In April, the FDA finalized a new expedited pathway for medium- and high-risk devices that meet an unmet need for certain serious medical conditions. Then, in June, the agency announced it would exempt some 120 classes of low-risk devices from premarket notification requirements, making it substantially easier to bring devices in those classes to market.

Unfortunately, none of those classes included orthopedic devices.