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Regulatory Focus™ > News Articles > FDA Data Show the Worst is Over for 510(k), PMA Submissions

FDA Data Show the Worst is Over for 510(k), PMA Submissions

Posted 17 May 2013 | By Alexander Gaffney, RAC

The medical device industry has long complained that the process of obtaining regulatory approval for its devices has become increasingly difficult over the course of the last decade. But in a presentation given to industry at a recent device conference, the US Food and Drug Administration's chief medical device regulator Jeffery Shuren had a message for manufacturers: The worst is over.

510(k): The Worst is Over

Shuren, the director of FDA's Center for Devices and Radiological Health (CDRH), presented a litany of data showing what industry has long claimed. For example, in 2002, 36% of 510(k) applications to the agency were returned to the sponsor with a request for additional information (AI), delaying approval. Fast forward to 2010, and that number had climbed to 77% for first-round AI requests-an increase of more than 100%.

The dramatic rise in AI requests left industry fuming, arguing that the 510(k) process, once a relatively simple way to get substantially equivalent devices approved, had turned into a lengthy and unpredictable  quagmire. But if Shuren's data is any indication, the tide of AI requests may be turning-albeit slowly-back in industry's favor.

Since 2010, when 77% of first-round 510(k) requests received an AI, each subsequent year has been either no worse or better than the previous. In 2011 and 2012, for example, FDA issued AIs to 75% of first-round applications. That marked the first decrease since 2002, though that number is still higher than it was in 2009. The first three months of 2013 have shown a continued downward trend, with just 73% of applications receiving the first-round AI.

However, AI decisions weren't the industry's only gripe with CDRH. The time it takes to obtain an approval has also skyrocketed in recent years, from a total of 90 days in 2005 (the low point) to 154 days as of 2010. The data show that the majority of this increase is attributable to more time taken by industry during the filing process. FDA has at times said this is due to a poor quality of device applications, while industry maintains the increase in AI requests means it takes more time to fully complete an application.

Again, Shuren had good news for applicants. According to preliminary cohort data (some devices submitted during 2011 and 2012 have not yet been approved), average decision times have fallen from their 2010 highs of 154 to just 124 days as of 2012. Shuren's data showed a 19-day improvement in industry time and eight days' improvement by FDA.

A more nuanced view of that data showed more modest improvement, with the average decision time falling from 128 days to 124 when accounting for 88.1% of decisions-a point of data likely to account for the average applicants' experience.

Another piece of good news for 510(k) applicants: A precipitous fall in substantial equivalence findings, which had plunged from 87% to 73% in just four years, seems to have rebounded slightly since 2010. In 2011, FDA found 78% of applications to be substantially equivalent, and 80% in 2012.


Shuren had similar news to share regarding PMAs. In recent years, FDA had more than doubled the number of premarket approval (PMA) applications issued a major deficiency letter, going from 40% in 2000 to 86% in 2010. But in the two following years, FDA has brought that number down to 70% and 71%, respectively. Those levels have not been seen at the agency since 2005, according to FDA's data.

That decrease has corresponded with a sharp decrease in the time it takes FDA to come to a decision, going from 464 days on average in 2009 to just 246 in 2012 (based on incomplete cohort data)-the lowest level in the past 12 years.

But approval decisions are a decidedly more mixed story. FDA's approval numbers have rebounded slightly since 2010 (59%) to 70% in 2011 and 2012, but those numbers are still far behind the 2003-2008 period, when FDA's approvals were as high as 90%.

Shuren's slides may be found here.

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