“I am delighted to say that Congress has passed legislation reauthorizing the four user fee programs that provide critical funding to the FDA for its human medical products activities,” FDA Commissioner Dr. Robert Califf said on Twitter.
He later tweeted: “It means that we will not need to begin the notification process for user fee-funded staff.”
The reauthorization generally maintains the existing fee structure, but it includes a new mechanism where the FDA will be able to increase fees in later years if it meets goals related to timely review of submissions.
Trade group AdvaMed also applauded the passage of the fifth iteration of the Medical Device User Fee Amendment (MDUFA V).
“The bipartisan passage of this historic five-year agreement…