IOM Calls 510(k) Process “Flawed”, Recommends FDA Develop New System

The long-awaited IOM report on the 510(k) framework was released this morning, and, not unexpectedly, the IOM found flaws in the system. Less expected was the recommendation that the 510(k) was beyond repair and the FDA should just start over.

One of the committee’s main findings was that the 510(k)’s substantial equivalence requirement does not prove safety and efficacy. As such, the group recommends that the 510(k) program be scrapped in favor of a system that does reasonably assure safety and efficacy. They say this transition should occur as quickly as possible, even noting the time it would take to design a new system. This is emphasized in an accompanying letter from the committee to CDRH director Jeff Shuren, wherein the IOM advised the FDA not allocate their “sparse resources” on revamping the 510(k), but instead focus on developing a more “rational” system. The report also made a case for heightened post-market surveillance and an initiative to assess whether its regulatory pathway for class II devices was hindering innovation.

While the IOM report was expected to address some of the more controversial proposals for reforming the 510(k) process, these recommendations may be more dramatic than anyone anticipated. The proposals effectively dismiss the public quibbling that’s gone on about the class IIb designation or the clarification of “indications for use” and “intended use”. However, to our knowledge, the FDA has never spoken of their intention of ditching the 510(k), and to do so would require a massive amount of resources and likely necessitate new legislation from Congress. The fact that the report makes such sweeping conclusions, rather than, for instance, simply supporting the creation of a class IIb, in our opinion significantly lowers the short-term risk for an overhaul of the 510(k). The FDA may still move forward on changes, but they’ve been hesitant on that front so far, and the agency has recently couched some of the pressure surrounding the IOM report by reminding stakeholders that they were not bound to the report and the IOM was simply providing recommendations.

The backlash against the IOM report began even before the report was released. The Washington Legal Foundation, which the New York Times describes as a “pro-business group”, has already argued that the report is biased based on the lack of representation from industry, the investment community and patients on the IOM’s panel. At the webcast that followed the release of the report, predictably, many of the questions revolved around the obstacles to implementing a new regulatory system. One Q&A speaker minced no words in calling the proposal a “practical and political non-starter”, and others highlighted the fact that the FDA has already said they didn’t want to get rid of the 510(k). The IOM’s response was generally that they stood by their recommendations and the FDA could use the report however they wanted.


Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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