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House user fee bill includes postmarket provisions

This article was originally published in The Silver Sheet

Executive Summary

Passed July 11, H.R. 2900 would allow FDA to collect $287 million in fees from device manufacturers over the next five years, and would commit the agency to meeting new premarket review performance goals. In addition, the bill authorizes $7.1 million a year in Congressional appropriations to help FDA collect, develop, review and evaluate postmarket safety information on medical devices. Other provisions would establish a unique device identification system; require a Government Accountability Office report on the prevalence and causes of hospital-acquired infections attributable to medical devices; require a GAO report on the "appropriate use" of the 510(k) premarket notification process; and clarify that a company can market a device while not carrying out FDA postmarket surveillance orders when the validity of the order is under formal FDA review at the company's request. The bill must now be reconciled with the Senate version (S. 1082), passed May 9. FDA Commissioner Andrew von Eschenbach urged Congress to approve a final, reconciled bill "as early in September as possible." The current user fee program expires Sept. 30
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