Aug 11 2011

Divisive Devices or UFC 510(k): FDA Meets IOM

In a previous post, I discussed the FDA’s Center for Devices and Radiological Health (CDRH) re-evaluation of the 510(k) review process for medical devices.  This re-evaluation, spearheaded by the very visible director of CDRH, Dr. Jeffrey Shuren, was prompted by industry complaints about the review process, arguments over the safety of cleared devices, and a silverscreen-worthy saga resulting in the bankruptcy of a medical device firm and the ousting of the previous CDRH head.  The re-evaluation process included both an extensive internal review by CDRH itself and an independent review by an Institutes of Medicine (IOM) committee composed of former FDA personnel, physicians, professors of law, an expert on information technology, and an insurance industry representative.  The internal review has been an ongoing effort but the external review culminated in last Friday’s much-anticipated official release of the IOM committee’s report titled “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.”

Be Careful What you Wish For

FDA asked the IOM committee to answer two principal (and very large) questions with their report:

  1. Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
  2. If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) process?

What the committee produced was likely far more than FDA had expected.  In one swoop, the committee not only found multiple flaws in the 510(k) review process, it recommended scrapping it altogether.  It was clear from remarks made by the committee chairman, Dr. David Challoner, during a Q&A session webcast the morning the IOM report was released, that the committee performed their evaluation with the safety and efficacy of devices in mind.  Although this approach seems reasonable, the current laws governing the 510(k) review process focus on substantial equivalence to a predicate device, rather than the evaluation of safety or efficacy calling into question the relevancy of the committee’s approach.

FDA’s response to the IOM report was lukewarm at best and comments from agency officials were aimed at reminding the public that the report is just another set of recommendations that will be taken into consideration as the agency determines future policy.  Dr. Shuren noted “FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.”  One point on which the two agencies do agree is that there does not presently exist a “public-health crisis related to unsafe or ineffective medical devices.”

The heart of the matter

At a quick glance, the net result of the entire process has been expenditure of significant taxpayer resources, valuable time by both agencies, and a large philosophy gap to bridge.  The real question remains ‑ has the 510(k) process proven to be a robust method to review medical devices eligible for this type of review under current law?  A look at recalls of 510(k)-cleared devices may be one way to help answer that question; however, several conflicting reports on the safety of cleared devices has only muddied the waters.  A report compiled by Ralph Hall, professor of law at the University of Minnesota, focuses on devices cleared through the 510(k) process and have been recalled under Class I recalls (the category that presents the most serious potential risk to users).  Hall’s report showed that less than 1% of devices that were cleared by the 510(k) process were Class I recalls and that figure drops to 0.22% when only premarket issues are considered.  One flaw with focusing on Class I recalls is that devices cleared through the 510(k) process are generally classified by FDA as Class I or II devices which are considered to pose low or moderate risk.  Thus, 510(k)-cleared devices are more likely to undergo Class II recalls (use of these devices carried a moderate health risk, or that the probability of serious adverse health consequences was remote) so Class II recall data may more accurately represent the safety of such devices.  Recall data must also be presented in the context of the denominators since the overwhelming majority of devices (99%, according to FDA) enter the market through the 510(k) review process.

The Government Accountability Office (GAO) published their own investigation into medical device recalls a month before the IOM released their report.  The GAO report found that 83% of the 700 devices recalled on average yearly between 2005 and 2009 were Class II recalls.  Their data also show that 87% of recalls were for devices which were cleared for market through the 510(k) process as compared to other FDA review processes.  Per available data, 73% of Class I recalls were for devices cleared through the 510(k) process.  Overall, according to the GAO, 4% of all devices recalled (including 510(k) and PMA) were categorized as Class I suggesting the general safety of marketed medical devices is quite good.

Now what?

As is customary upon release of its own reports and guidances, FDA plans to open a public docket to receive comments on the IOM report, and will hold a public meeting after digesting those comments.  Given the FDA’s swift dispensation of the IOM recommendations, they will likely end up basing the majority of changes to the 510(k) process on their previously released set of proposed changes.  The status and specifics of these changes is not clear as FDA has been modifying their proposed guidance, presumably with the expectation of useful suggestions by the IOM committee.  Some clarity was provided by William Maisel, the FDA’s deputy director of science, who recently said the agency will decide by the end of October whether the makers of medical devices that pose a moderate risk to patients should be required to provide more data to the FDA.

Although any FDA-IOM consensus on pre-marketing activities seems remote, post-marketing activity reform has gained notable attention from both groups.  In the IOM report, the committee openly criticized FDA’s current post-marketing surveillance methods, suggesting they are a “substantial weakness” and noting that FDA does not effectively use the resources at its disposal to ensure the post-marketing safety of cleared devices.  The agency is already developing new methods of post-market safety surveillance through its Sentinel safety data monitoring project.

In the meantime, device developers are no more certain about the future of the 510(k) process.  It seems the writing is on the wall as far as additional data requirements for some Class II devices but it remains to be determined whether that data needs to be collected in significant clinical studies before marketing or if more substantial post-marketing surveillance activities will be sufficient.

This is a post by Shane Grivna, Ph.D.  Shane is a Clinical Strategy Scientist for Cato Research and an Analyst for Cato BioVentures.