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Compliance In Focus
Posted by John Lehmann on Fri, Jan 29, 2016

FDA Hits User-Fee ERA Record

The number of original PMAs for completely high-risk devices and panel track supplements for major new FDA_Hits_User-Fee_ERA_Recordupdates approved by the FDA, was at its highest level since 2001.  Approvals increased to 56% in 2015 compared to the previous year and almost double the 2013 total.

So is this the new normal or just a one-year spike? 

According to William Maisel, the Center for Devices and Radiological Health’s chief scientist, and acting director of the of the Office of Device Evaluation, this should be view as a validation of process reforms CDRH put into place.  He also praised the hard work of the center’s reviewers.

The increased approval numbers also seem to match growing satisfaction in the industry with FDA’s handling of the review process.  According to Paul LaViolette, managing partner and chief operating office of SV LifeSciences, “the interactive responsiveness of FDA has gone up dramatically.” 

Of note, one factor driving the volume increase in 2015 was the increase in industry submissions.   The number of original PMAs filed with FDA in fiscal year 2015 (October 1, 2014-September 30, 2015) was significantly higher when compared to the prior three fiscal years.

Maisel argues that the increase in submissions is due to FDA reforms that have made the regulatory process more inviting in the US.  He indicates the device center has made enhancements to its appraisal of investigational device exemptions for early-stage and pivotal studies, speeding up the start of clinical trials.  In 2015, the number of IDEs approved on the first review cycle was 165, the most since 2002.  That number has been on an upward trend and he suggests the quicker path to trials is garnering more submission coming to the FDA and ultimately, more approvals.

Another positive trend is the average review times are declining. In an article in “The Gray Sheet” highlights that while there was a spike in the average total decision times for original PMAs filed with the FDA in FY 2013, the agency pointed out that there was an unusually high portion of PMAs that required advisory panel meeting that lengthened average times.  The number of panel meetings has returned to normal, leading to a decline in decision times.

Overall, the trend lines are very positive.  Do you believe this trend is sustainable or just a variation that will change again over time?  Share your thoughts with us.
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 photo credit: Graphic trend of glaciation in Rome via photopin (license)

Topics: FDA, CDRH, William Maisel, User Fee, Paul LaViolette


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