Overhauling The 510(k) Process

Law360, New York (August 19, 2011, 1:31 PM EDT) -- ­On July 29, 2011, the Institute of Medicine (IOM) released the long-awaited report of its Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process (IOM Committee). The report recommended replacing the current 510(k) process with an integrated premarket and postmarket regulatory framework, which would likely result in a longer and more expensive pathway to market for manufacturers of moderate-risk medical devices.

The IOM Committee’s Report (IOM Report) assessed the 510(k) process and made a host of recommendations. Notably, the IOM Report recommends that...
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