Hamburg: FDA is taking concerns over 510(k) changes seriously

10/21/2010 | MassDevice.com (Boston)

The FDA is conducting a thorough review of the public comments and "substantive concerns" regarding its proposed changes to the 510(k) process for clearing medical devices, said Dr. Margaret Hamburg, the agency's chief. During her speech at a conference in Washington, D.C., Hamburg said the FDA will provide explanations before adopting a proposal that raised a number of significant concerns among the industry.

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