Fixing / Demolishing the 510(k)

Monday, August 01, 2011

"The 510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device."
—IOM Report

The internet was all a-twitter Friday as the Institute Of Medicine (IOM) released its much-anticipated report on the 510(k) process. The report took two years to write, but major parts of it will take at least five or ten years to implement. If we even move that quickly.

It's tough to know exactly what to say about this report. The report makes a number of very solid observations and recommendations about the 510(k) process. The changes that it proposes are both radical and entirely sensible. Who knows how many business models it might disrupt and/or opportunitites this new system might create? It's not difficult to see why we're all talking about this, it's pretty heady stuff. It's the kind of change that the phrase "paradigm shift" actually describes.

But let's be serious for a moment: In the world we currently inhabit, the most significant changes this report proposes have exactly no chance of happening in any foreseeable future.

You'd like to think that Congress could use a report like this to carefully consider the best way to balance private gain and public interest. In reality, however, we have a Congress that can't seem to muster broad support for anything besides magical thinking. You get the feeling that if Obama had asked Congress for permission to go after Bin Laden, members would have held their breaths until he agreed to pay for the operation with tax cuts.

But back to the report. The substantial equivalence standard has many things to recommend it, but experience has revealed that is has at least as many weaknesses. And yet... for now, anyway... we're probably stuck with it.

I would advise anyone beginning work on a device today to pay very close attention to the recent RUO guidance and the numerous broad hints FDA has been dropping about LDTs. I don't expect the IOM report to be something that industry needs to do very much about for a while to come.

Even so, there's a kernel of potentially actionable stuff here. FDA might be able to implement some number of changes to the de novo 510(k) process without Congressional action. Doing so could potentially provide them with a opportunity to funnel new applicants toward the de novo process, thereby reducing the actual use of the substantial equivalence standard. That strategy would require a bit more inconsistency and opacity than what IOM envisions, but it has the advantage that it might actually be achievable.

In any event, it's food for thought. As much as the system does work in most cases, few of us beleive that it is  as good as it could be. If the IOM report helps guide us to the next improvement it will have succeeded, whether or not the improvement we make is the one they actually described.

Tags: 510(k), CDRH, Policy

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