Friday, June 19, 2009

FDA Medical Device Approval System "Broken"

From Reuters: Rep. Frank Pallone Jr. (D-NJ), chairman of the health subcommittee of the House Energy and Commerce Committee said that "there is evidence that the Food and Drug Administration (FDA) approval system for medical devices is 'broken' and a comprehensive review of the major issues and potential problems is needed." At a hearing Thursday, Rep. Pallone "said the standards, procedures, and rules for certain devices 'don't [meet] modern needs of getting medical devices to those in need with confidence in their safety,' and an approval process is required that keeps pace with new technology." During the hearing Marcia Crosse, the Government Accountability Office's director of healthcare, said "that the GAO has repeatedly pointed to shortcomings in the medical device approval process that continue today."

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