News Feature | February 29, 2016

FDA Touts Fastest-Ever PMA Approvals

By Jof Enriquez,
Follow me on Twitter @jofenriq

FDA Draft Guidance

The U.S. Food and Drug Administration (FDA) reports that, during the first three months of 2016, it approved premarket applications (PMA) for Class III medical devices at a record pace.

FDA in recent years had been criticized for slow device approval times, but the agency last year reported that reforms had sped up the average time to decision for PMAs at 262 days, the lowest since 2000, and markedly quicker than the 2015 average of 432 days to decision.

The pace continues to quicken, as FDA reports that, for the first three months of 2016, it only took them an average of 209 days to decide on PMA applications, 20 percent quicker than the agency’s 2015 pace (262 days). It's a record low time to decision for this type of application.

FDA also reported that it approved 91 percent of PMAs for the first quarter, down from an all-time high of 98 percent in 2015, but still significantly better than the 86 percent approval rate in 2014, 85 percent in 2013, 70 percent in 2012, and just 59 percent in 2010.

For 510(k) applications during the first three months of the year, FDA said it slashed its time to decision by 14 percent —from 127 days in 2014 to 109 days in 2015 — the quickest since 2006. It approved 85 percent of 510(k)s, equaling last year’s pace, and one percent higher than 2014.

FDA had acknowledged, based on its own performance review covering the decade from 2000 to 2010, that its premarket approval numbers were trending down. In response, it implemented a number of reforms to its approval process, including, but not limited to, streamlining clinical trials and introducing the Expedited Access Pathway Program and the Medical Device Development Tools (MDDT) Program.

"The agency implemented a number of new policies and programmatic changes over the past five years to improve its performance and to adapt its oversight to the global marketplace and to new technologies. Added funding and increased capacity, as the result of the 2012 reauthorization of MDUFA, also helped reverse the direction of the agency's medical device premarket program," FDA stated in a report published last year.

As a result, FDA then reported that total times to decision for all types of device submissions have sped up in the last five years, compared to the preceding decade, a trend that continues in the first three months of this year.