FDA to enact changes to 510(k) by September, devices chief says

02/22/2010 | Clinica (subscription required)

The FDA will hold town hall meetings to gather views on the 510(k) process in preparation for the implementation of the possible changes to the process by September, said Jeffrey Shuren, director of the agency's Center for Devices and Radiological Health. Meanwhile, the agency has started negotiations on the Medical Device User Fee Act, which is set to expire on Oct. 1, 2012.

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