FDA's Center for Devices and Radiological Health published the results of its analysis of decisions on 510(k) applications between 2006 and 2010 (see the pdf of the report here), including some data from as far back as 2001, and several features jump out to the casual observer. The problem for CDRH managers is that the report suggest a number of stories – several of which the agency fails to tell – that will do nothing to dial down industry's pushback against FDA's more aggressive enforcement/compliance regime. The report is also certain to do nothing to drain the increased pressure on FDA from the House of Representatives, which is no longer in the hands of legislators who are friendly to the intentions of the latest crop of managers at FDA.
One of the very interesting metrics depicted graphically in the report, which tells how many 510(k) applications were deemed not substantially equivalent (NSE), is that only about 1% of 510(k) applications filed in 2001 were deemed NSE, but the rate of NSE outcomes in 2010 was 8%. Granted it was not a jump straight from 1% to 8%, because the rate ran to 3-4% in the intervening years, but when you look at the time when Jeff Shuren, MD, took over at CDRH, it comes across as conspicuous. Remember that Shuren took the job at CDRH in January 2010. It might be a coincidence, but that seems wholly implausible.
The report also indicates that the percentage of NSE determinations chalked up to the use of new technology was a bit more than 10% in 2005 and 2006, but that ratio fell to 6-8% between 2007 and 2009. Then last year, the rate of NSE determinations triggered by the use of new technology was at 4%. So what is the casual observer to make of the agency's claim that new technology is imposing more drag on device applications?
One could conclude that new-technology 510(k) applications are nearly all going through because those applications are for the most part fairly tight. Given the agency's reluctance to brook anything suggestive of a new safety/efficacy issue, however, that explanation needs backing in order to acquire any credibility. It seems just as likely that the explanation is in the main that 510(k) applications are less likely to include new technological developments.
A very odd omission on FDA's part is seen in the first chart in the report. There are three categories of 510(k) outcomes, namely those determined substantially equivalent, those deemed NSE, and the unexplained group of applications under the title “other.”
The rates of determinations falling into this “other” group comes in at 16% in 2001 and at 19% last year, with a nadir at 9% for the years 2004-06. There seems to be little correlation with the arrival of the new administration at FDA, but how do the managers at CDRH not see a need to account for a category that consumed the fate of one in five 510(k) applications last year? The quick-and-dirty answer is that the sponsor just dropped the applications, but there are certainly a number of scenarios wrapped up in that explanation, assuming it has any merit.
One scenario is that the application was of lousy quality and the sponsor opted to let it go rather than waste more resources on a loser, but another possible picture is that FDA's reviewers so harassed the sponsor that the device went to Europe. There are yet other possible explanations, including that FDA deemed the application in need of a PMA, but the report is mum. As any public relations professional will tell you, imagination marches where information is absent, and this is a conspicuous omission.
All in all, this is a report that raises as many questions as it answers. Whether those answers will be forthcoming anytime soon is anyone's guess, but publishing things like this without adequate context does nothing to help the agency's credibility at a time when FDA needs all the credibility it can get.