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FDA Chief To Prioritize Medical Device Division

The US Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg said she will have a look at the Center for Devices and Radiological Health's approval process for 510(k) medical devices in an effort to deal with the criticisms of the division, according to The Wall Street Journal. FDA scientific experts have said some medical devices that received 510(k) approval should have been required to show more data on safety and efficacy.

There obviously have been some problems at the Center for Devices and Radiological Health, Dr. Hamburg said in an interview, calling it a high priority. Former FDA Commissioner David Kessler, who described the device center as dysfunctional, and in meltdown, said he has discussed the crisis at the device center with Dr. Hamburg.