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HEARING: #SubHealth to Continue User Fee Hearings, Examining MDUFA

Mar 21, 2017

WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), announced a hearing for Tuesday, March 28, 2017, at 10:15 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “Examining FDA’s Medical Device User Fee Program.”

The Medical Device User Fee Amendments (MDUFA), as reauthorized by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, supports the review and regulation of medical devices. The Health Subcommittee recently held a hearing examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), both of which also expire in September 2017, and will hold a hearing examining the Prescription Drug User Fee Act (PDUFA) on Wednesday. All of these user fee programs must be reauthorized by the end of Fiscal Year 2017.

“Medical devices play an increasingly important role in improving and often prolonging the lives of patients with a wide range of conditions and diseases,” said Chairman Burgess. “Both FDASIA and the 21st Century Cures Act included numerous provisions improving the device development and review process and I look forward to learning more about how the proposed MDUFA agreement would build upon these efforts to benefit patients and foster innovation.”

The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted.