Toss Out FDA’s 510(k) Process, Expert Panel Says

09-14-2011
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The Food and Drug Administration’s controversial 510(k) process, which provides medical devices a “fast track” to FDA approval if their manufacturer can demonstrate that the devices are “substantially equivalent” to products already on the market, cannot ensure that medical devices are safe and effective and should be scrapped entirely, an influential panel has recommended.

The panel, which was convened by the highly respected Institute of Medicine, released a report last month concluding that the 510(k) process lets medical product be put on the market with insufficient testing, based on their likeness to an older device that itself may never have been fully tested.

“The public thinks that if the FDA clears and ‘approves’ a device that safety and effectiveness has been considered. But that is not always the case,” David Challoner, a doctor who led the panel, told the Washington Post.

The FDA swiftly rejected the panel’s recommendation—despite the fact that the agency had sought its advice on the matter.

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