The FDA approved more pre-market approval (PMA) applications during 2015 than any year since 2001.
FDA Device Submissions and Approvals Climbing, Review Times Dropping
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In 2015, according to a March 23, 2016 note from Wells Fargo analyst Larry Biegelsen, 43 original PMAs were approved during the year. That’s more than the 25 approved in 2014 and more than double the approvals in 2013. Device approvals were led by the cardiovascular subsector of the industry with 14 approvals. Orthopedic devices approved in 2015 include Aesculap Implant Systems, LLC’s activL Artificial Disc; Biomimetic Therapeutics, LLC’s Augment Bone Graft; OrthogenRx, Incorporated’s GenVisc 850; and Cerapedics, Incorporated’s i-Factor Peptide Enhanced Bone Graft.
For 2016, the agency has already approved seven 7 PMA applications, slightly ahead of the 2015 pace that had five approvals through the same February time period. No orthopedic devices have been approved yet by the agency in 2016.
Biegelsen noted that 2015 supplemental approvals, which include design changes or label expansions to original approvals, totaled 19, compared to 14 and 10 in 2014 and 2013, respectively. The 2015 supplemental approval total appears to be the highest level on record. According to FDA documents, 16 of the 19 (84%) supplements were related to label changes.
Biegelsen attributes the approval volume to the increase in submission activity from device manufacturers and faster review times from the agency. To that point, the FDA reports that the average time to an original PMA decision in fiscal year 2015 (October – September) was 209 days, which compares to the 262 and 432-day average review times for 2014 and 2013, respectively. This acceleration of review times meets a promise from the agency to device makers to improve decision making consistency and shorten review times.
The number of submissions by device makers in fiscal 2015 increased to 72 original and supplementals. This is well above 2013 and 2014 levels of 45 and 43 submissions, respectively. Biegelsen points out that the fiscal 2015 original PMA approval rate of 98% represents a meaningful improvement in approval percentage, up from 86% in 2014 and 85% in 2013. He views this continued improvement in PMA turnaround time, elevated level of PMA submissions and high approval rates as positive indicators for the future of medtech innovation in the U.S.
If you want to see the FDA approvals for yourself, click here.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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