FDA faces problems in reviewing devices under 510(k), staffers say

02/18/2010 | Reuters

The FDA might have to clarify its guidelines and seek new regulations to address some of the problems in evaluating some medical devices under the 510(k) process, agency staffers said at a public meeting Thursday. Device firms and other industry experts said the current regulatory process does not need major changes, which could hamper research and prevent firms from delivering innovative products to patients and physicians.

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