FDA changes voting procedure of device expert panels

04/26/2010 | United Press International

Effective May 1, FDA advisory panels will cast their votes by ballot and based on the efficacy and safety of medical devices under review instead of voting to approve premarket applications, according to the agency. "By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes," said Dr. Jeffrey Shuren, director of the agency's Center for Devices and Radiological Health.

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