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F.D.A. to Seek New Standards on Human Test Data
New York Times - Barry Meier

The Food and Drug Administration is developing guidelines that will set tougher scientific standards for data from tests on humans that makers of medical devices submit when seeking approval of their products, a top agency official said. Dr. Jeffrey Shuren, the acting director of the Center for Devices and Radiological Health, said in a telephone interview on Monday that the F.D.A. most likely will soon urge device makers to take steps like using more sharply defined targets to measure the success of clinical trials.