FDA Must Strengthen Reviews For Risky Devices: FDA Head

Law360, New York (June 6, 2012, 3:32 PM EDT) -- U.S. Food and Drug Administration Commissioner Margaret Hamburg said Wednesday that the agency must beef up its medical device review process, which has come under fire over problems with products like surgical mesh that Johnson & Johnson recently announced it would stop selling.

Asked by Law360 whether the surgical mesh case and others warranted a review of the FDA's 510(k) process, under which the mesh was approved, Hamburg told reporters that the FDA was considering ways to tighten its approval processes.

“We have been taking a...
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