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MDUFA Hearing Tomorrow, FDA's Shuren to Testify

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By Alexander Gaffney

The House Energy and Commerce Committee is scheduled to hold a hearing on 15 February on the Medical Device User Fee Act (MDUFA) reauthorization. Testimony will be heard from Jeffery Shuren , the director of the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), and several other prominent industry and patient representatives.

FDA and industry representatives came to a deal “in principle” on the MDUFA legislation on 1 February that would see user fees increase from $287 million to $595 million over the coming five years.

In return for the fees, FDA will reportedly improve the speed and reliability of the device review process, hire an outside consultant to evaluate its review system and will meet with manufacturers in the middle of the device review process.

The Congressional hearing will explore this deal and CDRH’s activities since the last MDUFA reauthorization.

MDUFA Hearing In Brief:





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