Regulatory Focus™ > News Articles > Refuse-to-File Guidance, Intended to Improve 510(k) Review Efficiency, Fails to Show Effect in Repor

Refuse-to-File Guidance, Intended to Improve 510(k) Review Efficiency, Fails to Show Effect in Report

Posted 20 February 2014 | By Alexander Gaffney, RAC

If you've spoken with a regulatory affairs professional involved in the medical device space in recent years, you've probably already heard, anecdotally, that US device regulators seem to be taking more and more time to clear products through its 510(k) premarket notification pathway.

And according to new data compiled by the Emergo Group, they're right-to a point.

510(k) Clearance Report

The group, a consultancy, compiled data on 510(k) submissions going all the way back to 2006, when the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) was able to clear devices in just 110 days on average.

Just five years later, in 2011, the average time to approval had increased by more than two months to 176 days on average, before falling slightly to 166 days on average in both 2012 and 2013.

But Emergo's data also shows another interesting trend: It isn't just FDA that's taking longer to clear devices. FDA also permits a small number of third-party entities to review premarket submissions in a process known as Third Party Review. In 2006, it took just 38 days to clear a device application through this process from start to finish. By 2013, that average had increased almost two-fold to 72 days on average. While still significantly faster than FDA, these entities had also seen a marked increase in review times.

The good news for device regulatory professionals is that FDA still manages to approve most 510(k) submissions within six months, even accounting for stops in the review clock when FDA asks for additional information (AI). Around 28% were cleared within 3 months of submission in 2013, Emergo noted.

And as with previous studies, Emergo found that some device classes are cleared more easily by FDA than others. Dental devices, for example, took 186 days to clear on average, while radiology devices took just 121 days.

Refuse-to-File Guidance Fails to Show Effect

Emergo also makes note of a recent refuse-to-file policy guidance, which it postulated would have a positive effect on clearance times as FDA would no longer need to waste time on applications which were incomplete, improperly formatted or otherwise deficient.

"Yet, we have no seen evidence of this so far," Emergo wrote in its report.

Indeed, FDA's data shows no improvements from 2012 (166 days) to 2013 (166 days) in terms of average approval times, though it's possible that gains may have been realized in some areas but hidden by lapses in others.

And while FDA may have come down from its 2011 peak, when it approved applications in 176 days on average, it has a lot of work to do if it wants to get its approval times down even further.

Emergo's report follows its 2013 and 2012 reports on the same, as well as a 2013 report published by FDA in defense of its 510(k) clearance times.


Emergo Report

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