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PDUFA bill carries device language

This article was originally published in The Gray Sheet

Executive Summary

Prescription Drug User Fee Act reauthorization legislation, set for markup April 18 in the Senate Health, Education, Labor & Pensions Committee, would establish a publicly accessible database of all postmarket surveillances and studies of PMA-approved and 510(k)-cleared medical devices. The legislative language comes after CDRH has already voluntarily launched a public 1Web site tracking postmarket study progress (2"The Gray Sheet" April 2, 2007, p. 26). The bill also includes language, originally introduced by Senator Chris Dodd, D-Conn., last month, that would link pediatric device innovators with funding sources, allow profit for humanitarian-device-exempted devices and mandate postmarket surveillance studies for pediatric devices (3"The Gray Sheet" April 2, 2007, p. 25). In addition, the legislation formally encourages reauthorization of the Medical Device User Fee and Modernization Act of 2002, which, like the drug user fee program, needs to be reauthorized before Sept. 30 when it is set to expire...

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