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Calls For More FDA Training In Lead Up To User-Fee Negotiations

Device firms will be pushing for more reviewer consistency and to avoid a major increase in fees during upcoming negotiations with FDA to reauthorize the Medical Device User Fee Act. The MDUFA IV reauthorization process starts as Congress is already considering major regulatory reforms and will finish under a new administration in the White House.

Industry groups say they will be pushing for increased FDA staff training to achieve wider consistency among its device reviewers in the lead up to negotiations for the fourth iteration of the medical device user fee program.

At the same, sector representatives are warning against a major increase in company user fees, instead calling for adequate support...

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