The 510(k) pathway: Changes may be coming

By Mary Ann Porucznik with Jeanie Kennedy

Investigation by IOM raises concerns about the future of the 510(k) pathway

On Sept. 23, 2009, the U.S. Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to study the premarket notification program—known as the 510(k) process—used to review and clear most medical devices marketed in the United States.

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