Studies find faults in FDA approval process for cardiac devices

12/29/2009 | Wall Street Journal, The ·

The FDA approves some heart devices based on a single clinical study and other inadequate standards, according to two studies published separately in two medical journals. Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, said the agency has started developing tougher standards and has called on firms to collaborate with the FDA in creating specific objectives for their clinical trials.

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