Hamburg says FDA working to address problems at device unit
FDA Commissioner Margaret Hamburg said the agency is seeking a new chief for the device unit and is working to address issues related to the division, including a formal review of the 510(k) process. "There have been some questions raised about the appropriateness of the approvals of medical devices, and that's going to get a hard look. That's fine, it should," said Michael Mussallem, AdvaMed's chairman and CEO of Edwards Lifesciences, at the Reuters Health Summit.
Reuters
| 11/12
This story published in AdvaMed SmartBrief on 11/16/2009
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