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Hamburg: Neither U.S. Nor EU Device Regulation Has It Completely Right

During her final public appearance at the National Press Club, outgoing FDA Commissioner Margaret Hamburg defended her tenure and said she was leaving a stronger FDA than the one she inherited. Asked about the agency's device regulatory process, she said she didn't know if FDA or Europe had struck the right balance but said more work needs to be done.

FDA Commissioner Margaret Hamburg says FDA is still honing its medical device regulatory process so that it strikes a balance between patient safety and industry's desire to market their products. But she says she is not sure the U.S. or the Europeans have gotten that balance right yet.

Speaking during what was probably her last public appearance at the National Press Club in Washington, D.C., Hamburg told journalists that she has been fascinated during her tenure by the...

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