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A prestigious medical organization, asked to analyze the Food and Drug Administration’s “fast-track” approval process for medical devices, took nearly two years to conclude that:

  • The process is fundamentally flawed and should be scrapped;
  • Even though it hasn’t actually approved any unsafe or ineffective devices;
  • And the organization has no specific recommendations for a replacement process.

Can you blame the FDA for responding, in effect, “Um, thanks, guys; we’ll keep your suggestions in mind”?

In September 2009, the FDA asked the Institute of Medicine (IOM), a federally chartered but independent advisory group, for its thoughts about the FDA’s 510(k) clearance process for medical devices (including imaging machines). The 510(k) process allows certain products to be quickly cleared for sale and use if they are substantially equivalent to devices already on the market.

Last Friday, the IOM finally announced its report. It said the FDA had asked two questions: “Does the current 510(k) process protect patients optimally and promote innovation?” “If not, what legislative, regulatory, or administrative changes are recommended?”

To the first question, the IOM responded:

The IOM finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework.

In other words, the FDA should expend its “finite resources” on asking Congress, including a House of Representatives that is virulently suspicious of government regulation, for a new regulatory framework. Good luck with that.

And why should the FDA embark on this suicide mission? Are bad devices slipping through? Well, no. Using italics for emphasis, the IOM declared: “The committee is not suggesting that all, many, or even any medical devices cleared through the 510(k) process and currently on the market are unsafe or ineffective.

As for the second question, the IOM listed a set of criteria for a new device-approval process: it should “be based on sound science,” “be clear, predictable, straightforward, and fair,” etc.

The IOM did not, however, propose an actual process. One IOM committee member, William W. Vodra, JD, former senior counsel at Arnold & Porter law firm, said proposing a new process was “well beyond our mandate,” according to HealthImaging.com.

Apparently, “what legislative, regulatory, or administrative changes are recommended?” does not constitute a mandate to recommend legislative, regulatory, or administrative changes.

In essence, the IOM suggested not-really-a-solution for not-quite-a-problem.

The FDA said it would take public comments about the IOM report. In the news release, you can almost hear Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, speaking through clenched teeth:

We appreciate the IOM’s report on the 510(k) program, and agree that the public should continue to feel confident in the medical devices on the market today. … 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.

We suspect that the next time the FDA asks the IOM for advice will be never.

Related seminar: Radiology Review


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