Posted 23 October 2014
By Alexander Gaffney, RAC
A new analysis by the California Healthcare Institute (CHI) indicates that after years of unprecedentedly high review times, the US Food and Drug Administration is finally beginning to accelerate the pace at which it reviews innovative high-risk medical devices.
The data, contained in CHI's report, Taking the Pulse of Medical Device Regulation and Innovation, found broad improvement at FDA's Center for Devices and Radiological Health (CDRH), which has been repeatedly criticized by members of the device industry in recent years over the slowing pace of its reviews.
As CHI's report recounts, "Medical device approval times at the FDA had slowed across the board," with both high-risk and low-risk devices subject to "considerably" longer review times relative to earlier in the decade. Thing had gotten so bad, CHI notes, that the review times were slower on average than they had been before the device industry began marshalling resources to FDA under the MDUFA programs. Those programs also included mandatory timelines meant to make FDA's review processes more timely and predictable.
Faced with the growing review times, many device companies now market their products abroad before marketing them in the US, the report notes.
Mostly Good News for PMAs
In recent years, however, FDA seems to be making progress in making its review processes more expedient, CHI found.
In 2012, FDA approved high-risk devices through its premarket approval application (PMA) process in 297 days on average—faster than any year going back to the year 2000, when it approved PMAs in 252 days on average. The 297-day figure also represents the third consecutive year of review improvements for the agency, shaving nearly 170 days off its 2008 and 2009 review averages (463/464 days).
"Data suggests that the PMA classes of 2011 and 2012 will show the best overall review-time performance of the device user fee era," CHI remarked.
While some data from 2013 is available, the majority of the cohort was not approved at the time the report's data was compiled.
The report also notes that of the PMAs that are given a decision, more devices are being approved now than at any time since the year 2000. In 2012, 54% of devices given an approval decision by FDA were approved, while 17% were rejected and 17% were returned with requests for additional data. That's a substantial improvement for industry compared to 2009, when FDA approved just 16% of devices and rejected 31%.
PMA backlogs are also now at their lowest level at the agency since 2010, with just 52 applications pending in 2013 compared to 93 in 2010.
Not all news in the report is positive for FDA, however. CDRH is making decisions about fewer devices now than at any time in the last decade. The agency made decisions about just 12 devices in 2013—half the number it made in 2012 and less than a third of the 42 decisions it made in 2011. CHI also notes that most products approved through the PMA process lag their EU counterparts by an average of 46.3 months (2008-212).
510(k) Applications a More Mixed Picture
CHI's report also looks at 510(k) applications—also known as premarket notifications—which are used by FDA to clear lower-risk devices which are substantially equivalent to already-approved products.
"While PMA approval times seem to have turned the corner, the same cannot be said for clearance of 510(k) products, which represent that vast majority of devices (over 3,000 annually) reviewed by the FDA," CHI wrote in the report.
510(k) review times continue to hover around historically high review times, with 3,980 applications reviewed in 160 days on average in 2012—the third longest average review time on record behind just 2011 (164 days) and 2010 (170 days).
The good news: As with PMAs, FDA has succeeded in vastly reducing the number of backlogged 510(k) applications at the agency since 2012, reducing the backlog from 1,839 to just 1,402. Since 2005, FDA has only reduced the backlog in one other year.
De Novo Data
The report also contains information about an increasingly used regulatory pathway: the de novo pathway, which is used to clear lower-risk devices which lack the predicate needed to utilize the 510(k) review pathway. FDA granted a whopping 19 de novo petitions in 2013—almost twice the previous record of 11 petitions granted in 2011. The surge is due to the simplification of the de novo petition process, CHI explained.
Taking the Pulse of Medical Device Regulation and Innovation