Report: IOM review of the FDA 510(k) process due Friday
July 27, 2011
The IOM’s report is expected to suggest reforms for the FDA’s 510(k) clearance process. This so-called “fast-track” process mostly applies to moderate-risk, Class 2 devices, such as most radiological equipment. Under this process, devices get cleared for the market merely by showing “substantial equivalence” with a currently available device.
But the 510(k) process has been controversial both with industry lobbies and patient advocates. Device manufacturers feel the process has slowed recently, and that rulings are often arbitrary and inconsistent. Patient advocates complain that dangerous or unproven products can get whisked through without proper testing.
Last year, the FDA proposed a series of its own reforms to the 510(k) process, in an attempt to please both groups. The agency intends to create a new category, Class 2b, for slightly riskier devices, and also require the clearance process to be more transparent.
The IOM, famous for revamping hospital safety with its 1999 report, “To Err Is Human,” was tapped by the FDA to review the 510(k) process in September 2009.
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