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FDAnews Device Daily Bulletin
April 3, 2012 | Vol. 9 No. 66
Shuren Predicts CDRH ‘Death Spiral’ Absent Timely MDUFA Passage
CDRH would move into a “death spiral” if Medical Device User Fee Act (MDUFA) legislation is not reauthorized this summer, director Jeffrey Shuren warned at a Senate Health, Education, Labor & Pensions (HELP) committee hearing Thursday. The current round of MDUFA expires Sept. 30, and federal policies require a 60-day notification period before ending employment. If reauthorization legislation isn’t passed or well on its way by late July, the center will need to begin talking to the 250 workers whose jobs depend on the device user fee program, Shuren said. And “once people know this is happening, more employees leave.”
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