FDA Taps IOM To Study Premarket Approval Process

Law360, New York (September 24, 2009, 1:31 PM EDT) -- The Institute of Medicine has been commissioned by the U.S. Food and Drug Administration to scrutinize the premarket notification program under which certain medical devices marketed in the U.S. are reviewed and cleared. The agency's processes were criticized earlier this year for allowing faulty devices on the market at patients' peril.

The IOM, a nonprofit that is part of the U.S. National Academy of Sciences, will examine the premarket notification program, also called the 510(k) process, for medical devices, the FDA said Wednesday.

While the IOM...
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